Artificial Intelligence-Enabled Medical Devices
The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate artificial intelligence (AI).
The AI-Enabled Medical Device List is a resource intended to identify AI-enabled medical devices that are authorized for marketing in the United States. Digital health innovators can refer to this list to gain insights into the current device landscape and regulatory expectations, which can help foster innovation and ensure public safety. This list can also provide transparency for healthcare providers and patients to clearly identify when medical devices use AI technologies.
Contents of the AI-Enabled Medical Devices List:
- The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the device’s overall safety and effectiveness, which includes an evaluation of study appropriateness for the device’s intended use and technological characteristics.
- A direct link to the FDA’s database entry of an AI-enabled medical device is provided. The database entry contains releasable information, such as summaries of safety and effectiveness. Note, the summaries are not all inclusive and do not include most of the information that may be submitted in an application.
- The list is not a comprehensive resource of AI-enabled medical devices. Instead, the list includes AI-enabled medical devices that were identified primarily based on the use of AI-related terms in the summary descriptions of their marketing authorization document and/or the device’s classification. The set of AI terms is based on the FDA Digital Health and Artificial Intelligence Glossary.
- To support transparency in the use of modern AI technologies, the FDA will explore methods to identify and tag medical devices that incorporate foundation models encompassing a wide range of AI systems, from large language models (LLMs) to multimodal architectures. This identification will help innovators, healthcare providers, and patients recognize when LLM-based functionality is present in a medical device. To facilitate the FDA’s development of methods to identify AI-enabled medical devices more easily, including identifying those devices incorporating LLM-based functionality in a future update of this list, sponsors are encouraged to include appropriate information in their public summaries.
This list will continue to be updated periodically. AI-enabled medical devices that have received authorization but for which decision summaries have not been published within the data collection period will be incorporated into a subsequent update.
Send questions or feedback on this list to digitalhealth@fda.hhs.gov.
AI-Enabled Medical Devices List
Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.
Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA's publicly available information.
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Date of Final Decision | Submission Number | Device | Company | Panel (lead) | Primary Product Code |
---|---|---|---|---|---|
05/30/2025 | K251406 | BriefCase-Triage | Aidoc Medical, Ltd. | Radiology | QAS |
05/30/2025 | K250236 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. | Radiology | LNH |
05/30/2025 | K243863 | Opulus™ Lymphoma Precision | Roche Molecular System | Radiology | QIH |
05/30/2025 | K243005 | AudaxCeph Cephalogram Analysis Software | Audax d.o.o. | Radiology | QIH |
05/30/2025 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., LTD. | Hematology | POV |
05/30/2025 | DEN240047 | Allix5 | Clairity, Inc. | Radiology | SEZ |
05/29/2025 | K250543 | Voluson™ Performance 16; Voluson™ Performance 18 | GE Medical Systems Ultr | Radiology | IYN |
05/28/2025 | K243378 | Rapid MLS | iSchemaview Inc. | Radiology | QIH |
05/28/2025 | K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging | Radiology | QKB |
05/28/2025 | K250367 | CoLumboX | Smart Soft Healthcare AD | Radiology | QIH |
05/27/2025 | K250932 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular | DQK |
05/23/2025 | K250005 | Clever One | Ewoosoft Co., Ltd | Radiology | QIH |
05/23/2025 | K243989 | Second Opinion® 3D | Pearl, Inc. | Radiology | QIH |
05/23/2025 | K243937 | Accuro 3S | Rivanna Medical, Inc. | Radiology | IYO |
05/23/2025 | K242594 | DEEPECHO | DeepEcho | Radiology | IYN |
05/21/2025 | K251276 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | Radiology | LNH |
05/21/2025 | K243866 | InVision Precision Cardiac Amyloid | InVision Medical Techno | Cardiovascular | SDJ |
05/21/2025 | K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
05/21/2025 | K243762 | Synapse 3D Base Tools (V7.0) | FUJIFILM Corporation | Radiology | QIH |
05/21/2025 | K243122 | uMR Omega | Shanghai United Imaging | Radiology | LNH |
05/20/2025 | K250370 | SCENARIA View Phase 5.0 | FUJIFILM Corporation | Radiology | JAK |
05/16/2025 | K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging | Radiology | JAK |
05/16/2025 | K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote S.p.A. | Radiology | IYN |
05/16/2025 | K240554 | InferRead Lung CT.AI | Infervision Medical Tech | Radiology | OEB |
05/16/2025 | K250086 | OTS Hip | Ortoma AB | Neurology | OLO |
05/14/2025 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging | Radiology | QIH |
05/14/2025 | K242437 | Smile Dx® | Cube Click, Inc. | Radiology | MYN |
05/09/2025 | K251126 | SKOUT system | Iterative Health | Gastroenterology-Urology | QNP |
05/09/2025 | K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound LLC | Radiology | IYN |
05/09/2025 | K243812 | Volta AF-Xplorer | Volta Medical | Cardiovascular | DQK |
05/09/2025 | K243230 | Second Opinion® BLE | Pearl Inc. | Radiology | QIH |
05/09/2025 | K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., LTD. | Hematology | POV |
05/08/2025 | K250226 | Clarius Median Nerve AI | Clarius Mobile Health Co | Radiology | QIH |
05/07/2025 | K243684 | BrightHeart View Classifier | BrightHeart | Radiology | QIH |
05/05/2025 | K243893 | Second Opinion® Pediatric | Pearl, Inc. | Radiology | MYN |
05/02/2025 | K251071 | Fetal EchoScan (v1.1) | BrightHeart | Radiology | POK |
05/02/2025 | K242583 | AT-Patch (ATP-C130/ATP-C70) | ATsens Co.,Ltd. | Cardiovascular | DSH |
05/01/2025 | K250087 | Vscan Air | GE Medical Systems Ultr | Radiology | IYN |
04/30/2025 | K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Canon Medical Systems | Radiology | QIH |
04/28/2025 | K243376 | uAngio AVIVA CX | Shanghai United Imaging | Radiology | OWB |
04/24/2025 | K243239 | Lung AI (LAI001) | Exo Inc | Radiology | MYN |
04/23/2025 | K250831 | Annalise Enterprise | Annalise-AI | Radiology | QFM |
04/21/2025 | K243651 | VersaViewer | GE Medical Systems SCS | Radiology | LLZ |
04/17/2025 | K243878 | CLARUS (700) | Carl Zeiss Meditec, Inc. | Ophthalmic | QER |
04/17/2025 | K242129 | VitalRhythm | VitalConnect, Inc. | Cardiovascular | DQK |
04/16/2025 | K243853 | Clarius Prostate AI | Clarius Mobile Health Co | Radiology | QIH |
04/16/2025 | K242500 | LARALAB | LARALAB GmbH | Radiology | QIH |
04/15/2025 | K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta Ltd. | Radiology | JAK |
04/11/2025 | K243558 | Canvas Dx | Cognoa, Inc. | Neurology | QPF |
04/11/2025 | K242748 | Oncospace | Oncospace, Inc. | Radiology | MUJ |
04/11/2025 | K242600 | Second Opinion Periapical Radiolucency Contours | Pearl Inc. | Radiology | MYN |
04/11/2025 | K250416 | GBrain MRI | Galileo CDS, Inc | Radiology | QIH |
04/10/2025 | K250754 | cmAngio® (V1.6) | CureMetrix, Inc. | Radiology | QIH |
04/10/2025 | K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
04/10/2025 | K243145 | syngo.CT LVO Detection | Siemens Medical Solutio | Radiology | QAS |
04/09/2025 | K243743 | autoSCORE (V 2.0.0) | Holberg EEG AS | Neurology | OMB |
04/08/2025 | K242295 | BunkerHill BMD | BunkerHill Health | Radiology | KGI |
04/07/2025 | K243567 | Tyto Insights for Rhonchi Detection | Tyto Care Ltd. | Anesthesiology | PHZ |
04/04/2025 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories | Radiology | MUJ |
04/04/2025 | K243769 | QFR (3.0) | QFR Solutions bv | Radiology | QHA |
04/04/2025 | K242807 | HeartFocus (V.1.1.1) | Deski | Radiology | QJU |
04/04/2025 | K241982 | DeepFoqus (DeepFoqus-Accelerate) | Foqus Technologies Inc. | Radiology | QIH |
04/03/2025 | K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare Gm | Radiology | QIH |
04/02/2025 | K241984 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | Radiology | QIH |
04/01/2025 | K242925 | MR Contour DL | GE HealthCare | Radiology | QKB |
03/31/2025 | K242166 | TribusConnect | TribusMed Beheer BV | Radiology | QIH |
03/27/2025 | K242745 | AI-Rad Companion Organs RT | Siemens Healthcare Gm | Radiology | QKB |
03/27/2025 | K243038 | Salix Central | Artrya Limited | Radiology | QIH |
03/27/2025 | K242919 | V5med Lung AI | V5med Inc. | Radiology | OEB |
03/26/2025 | K243891 | EarliPoint System | EarliTec Diagnostics | Neurology | QPF |
03/26/2025 | K243831 | Rayvolve LN | AZmed | Radiology | MYN |
03/21/2025 | K243808 | Rayvolve PTX-PE | AZmed | Radiology | QFM |
03/21/2025 | K250186 | GoLIF! Lumbar Interbody Fusion System | GetSet Surgical, SA | Orthopedic | MAX |
03/20/2025 | K243292 | brAIn™ Shoulder Positioning | Avatar Medical | Radiology | LLZ |
03/20/2025 | K241961 | Vent Creativity Knee v1.0 (Hermes) | Vent Creativity | Radiology | QIH |
03/19/2025 | K250042 | PeekMed web | Peek Health, S.A. | Radiology | QIH |
03/19/2025 | K243689 | AVIEW | Coreline Soft Co., Ltd. | Radiology | QIH |
03/18/2025 | K242683 | QP-Prostate® CAD | Quibim S.L. | Radiology | QDQ |
03/17/2025 | K250379 | SIGNA Prime Elite | GE Medical Systems, LLC | Radiology | LNH |
03/17/2025 | K243862 | LVivo Software Application | DiA Imaging Analysis Ltd. | Radiology | QIH |
03/14/2025 | K241960 | DeepRESP | Nox Medical ehf | Neurology | OLZ |
03/14/2025 | K243353 | One-Fil Putty | MEDICLUS CO., LTD. | Dental | KIF |
03/13/2025 | K250255 | xvision Spine system | Augmedics Ltd. | Neurology | SBF |
03/11/2025 | K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Cor | Radiology | MYN |
03/07/2025 | K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | Radiology | QIH |
03/06/2025 | K243331 | LVivo Seamless | DiA Imaging Analysis Ltd. | Radiology | QIH |
03/05/2025 | K241770 | Prostate MR AI (VA10A) | Siemens Healthcare Gm | Radiology | QDQ |
03/04/2025 | K243933 | Ceevra Reveal 3+ | Ceevra, Inc. | Radiology | QIH |
03/03/2025 | K243611 | JLK-SDH | JLK, Inc. | Radiology | QAS |
03/03/2025 | K243235 | LVivo Software Application | DiA Imaging Analysis Ltd. | Radiology | QIH |
02/28/2025 | K242798 | Airmod | Heroic Faith Internationa | Anesthesiology | BZQ |
02/28/2025 | K241922 | Myomics | Phantomics Inc. | Radiology | QIH |
02/27/2025 | K241620 | ChestView US | Gleamer SAS | Radiology | MYN |
02/26/2025 | K241222 | Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics L | Radiology | QIH |
02/26/2025 | K241546 | aiCockpit AI Viewer | Fovia, Inc. | Radiology | LLZ |
02/25/2025 | K243446 | 3DXR | GE Medical Systems SCS | Radiology | OWB |
02/25/2025 | K242967 | Loss of Pulse Detection | Fitbit | Cardiovascular | SDY |
02/25/2025 | K242822 | ART-Plan+ (v.3.0.0) | Therapanacea SAS | Radiology | MUJ |
02/24/2025 | K242994 | OncoStudio (OS-01) | OncoSoft. Co., Ltd. | Radiology | QKB |
02/21/2025 | K243614 | Sonio Suspect | Sonio | Radiology | POK |
02/21/2025 | K242838 | QuickRad | Aikenist Technologies Pv | Radiology | LLZ |
02/21/2025 | K242607 | ScanDiags Ortho L-Spine MR-Q | ScanDiags AG | Radiology | QIH |
02/20/2025 | K242240 | CaRi-Plaque | Caristo Diagnostics Ltd. | Radiology | LLZ |
02/20/2025 | K242447 | Falcon HST | Compumedics Limited | Neurology | OLV |
02/20/2025 | K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.AI, Co., Ltd. | Radiology | QAS |
02/14/2025 | K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | Radiology | POK |
02/14/2025 | K243696 | AVIEW CAC | Coreline Soft Co., Ltd. | Radiology | QIH |
02/14/2025 | K250248 | BriefCase-Triage | Aidoc Medical, Ltd. | Radiology | QAS |
02/12/2025 | K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutio | Radiology | JAK |
02/12/2025 | K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound Sy | Samsung Medison Co., Lt | Radiology | IYN |
02/12/2025 | K243250 | SubtleHD (1.x) | Subtle Medical, Inc. | Radiology | QIH |
02/11/2025 | K243620 | Vivid iq | GE Medical Systems Ultr | Radiology | IYN |
02/11/2025 | K243628 | Vivid T9/Vivid T8 | GE Medical Systems Ultr | Radiology | IYN |
02/10/2025 | K241659 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound LLC | Radiology | QIH |
02/06/2025 | K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
02/05/2025 | K241593 | BoneMetrics (US) | Gleamer SAS | Radiology | QIH |
02/03/2025 | K243268 | TipTraQ (TTQ001) | PranaQ Pte. Ltd. | Anesthesiology | MNR |
02/03/2025 | K250035 | Contour ProtégéAI+ | MIM Software Inc. | Radiology | QKB |
01/30/2025 | K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S. | Orthopedic | KWS |
01/29/2025 | K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technolo | General and Plastic Surgery | GEH |
01/28/2025 | K244027 | SANSA HSAT | Huxley Medical | Anesthesiology | MNR |
01/27/2025 | K243229 | Bunkerhill AVC | BunkerHill Health | Radiology | JAK |
01/24/2025 | K244023 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye LTD | Gastroenterology-Urology | QNP |
01/24/2025 | K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | Neurology | HAW |
01/24/2025 | K241232 | Galen™ Second Read™ | Ibex Medical Analytics Lt | Pathology | QPN |
01/23/2025 | K243158 | TeraRecon Aorta.CT (1.1.0) | TeraRecon, Inc. | Radiology | QIH |
01/22/2025 | K243350 | Rapid Neuro3D | iSchemaView, Inc. | Radiology | QIH |
01/21/2025 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | Orthopedic | QHE |
01/17/2025 | K241949 | Digital Color Doppler Ultrasound System (P60 Series) | Sonoscape Medical Corp. | Radiology | IYN |
01/17/2025 | K242171 | TechCare Trauma | Milvue | Radiology | QBS |
01/17/2025 | K242825 | Prenuvo Body Composition | Prenuvo | Radiology | LNH |
01/16/2025 | K242522 | Second Opinion CC | Pearl Inc. | Radiology | MYN |
01/15/2025 | K243065 | Cardiac Guidance | Caption Health, Inc. | Radiology | QJU |
01/14/2025 | K241166 | uCT 550 | Shanghai United Imaging | Radiology | JAK |
01/13/2025 | K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta Ltd. | Radiology | JAK |
01/13/2025 | K243950 | ARVIS® Shoulder | Kico Knee Innovation Co | Neurology | SBF |
01/10/2025 | K241676 | TriVerity | Inflammatix, Inc. | Microbiology | PRE |
01/10/2025 | K241891 | ScreenDx | Imvaria, Inc | Radiology | QWO |
01/10/2025 | K241009 | PeriCALM Patterns 3.0 | PeriGen, Inc. | Obstetrics and Gynecology | HGM |
01/07/2025 | K241079 | uCT 780 | Shanghai United Imaging | Radiology | JAK |
01/07/2025 | K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
01/06/2025 | K243481 | TMINI Miniature Robotic System | THINK Surgical, Inc. | Neurology | OLO |
01/06/2025 | K242488 | Soteria E-View | Omega Medical Imaging, | Radiology | JAA |
01/06/2025 | K242123 | Brainomix 360 e-CTA | Brainomix Limited | Radiology | LLZ |
01/03/2025 | K241350 | Clarify DL | GE Medical Systems Isra | Radiology | LLZ |
01/03/2025 | K243363 | JLK-ICH | JLK, Inc. | Radiology | QAS |
01/02/2025 | K242334 | Ezra Flash | Ezra AI, Inc. | Radiology | QIH |
01/02/2025 | K241696 | Ortho AI | Ortho AI LLC | Radiology | QIH |
12/27/2024 | K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | Neurology | HAW |
12/23/2024 | K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems | Radiology | JAK |
12/20/2024 | K242362 | Lightning Viewer | Nexsys Electronics Inc. d | Radiology | LLZ |
12/20/2024 | K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultr | Radiology | IYN |
12/19/2024 | K243705 | Saige-Density (2.5.0) | DeepHealth, Inc | Radiology | QIH |
12/19/2024 | K243688 | Saige-Dx (3.1.0) | DeepHealth, Inc. | Radiology | QDQ |
12/19/2024 | K242467 | IQ-UIP | Imbio, Inc. | Radiology | QWO |
12/19/2024 | K242270 | OrthoNext Platform System | Orthofix Srl | Radiology | QIH |
12/16/2024 | K240793 | MSKai | MSKai | Radiology | QIH |
12/12/2024 | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging | Radiology | KPS |
12/12/2024 | K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
12/11/2024 | K243548 | BriefCase-Triage | Aidoc Medical, Ltd. | Radiology | QFM |
12/10/2024 | K242461 | IRISeg | Intuitive Surgical Inc. | Radiology | QIH |
12/10/2024 | K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound S | Samsung Medison Co., Lt | Radiology | IYN |
12/09/2024 | K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | Radiology | QKB |
12/06/2024 | K240926 | PeekMed web | Peek Health, S.A. | Radiology | LLZ |
12/06/2024 | K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.AI, Co., Ltd. | Radiology | QAS |
12/06/2024 | K241543 | DrAid™ for Liver Segmentation | VinBrain Joint Stock Com | Radiology | QIH |
12/06/2024 | K240680 | CDM Insights | Oxford Brain Diagnostics | Radiology | QIH |
12/04/2024 | K241197 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular | DQK |
12/03/2024 | K242188 | ClearRead CT CAC | Riverain Technologies, I | Radiology | JAK |
11/27/2024 | K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
11/27/2024 | K240645 | Sonix Health | Ontact Health Co., Ltd | Radiology | QIH |
11/26/2024 | K241390 | NeuroMatch | LVIS Corporation | Neurology | OMB |
11/25/2024 | K241831 | Transpara (2.1.0) | ScreenPoint Medical B.V. | Radiology | QDQ |
11/22/2024 | K242094 | Dreem 3S | Beacon Biosignals, Inc. | Neurology | OLZ |
11/22/2024 | K242203 | BriefCase-Quantification | Aidoc Medical, Ltd. | Radiology | QIH |
11/20/2024 | K242359 | Strain AI (SAI001) | Exo Inc | Radiology | QIH |
11/19/2024 | K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic U | Siemens Medical Solutio | Radiology | IYN |
11/18/2024 | K241747 | Saige-Dx | DeepHealth, Inc | Radiology | QDQ |
11/18/2024 | K241633 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | Cardiovascular | QME |
11/15/2024 | K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno Inc. | Radiology | QFM |
11/15/2024 | K242062 | 1CMR Pro | Mycardium AI Limited | Radiology | LLZ |
11/15/2024 | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | Cardiovascular | SDJ |
11/15/2024 | K242800 | The 5000 Compact Series Ultrasound Systems | Philips Ultrasound LLC | Radiology | IYN |
11/15/2024 | K242130 | Koios DS | Koios Medical, Inc. | Radiology | POK |
11/14/2024 | K242342 | Fetal EchoScan | BrightHeart | Radiology | POK |
11/08/2024 | K240417 | ProFound Detection (V4.0) | iCAD, Inc. | Radiology | QDQ |
11/07/2024 | K241719 | NeuroICH | Neurocareai Inc. | Radiology | QAS |
11/07/2024 | K240712 | icobrain aria | icometrix NV | Radiology | QBS |
11/05/2024 | K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | TeraRecon,Inc. | Radiology | QIH |
10/30/2024 | K241108 | RemedyLogic AI MRI Lumbar Spine Reader | Remedy Logic Inc. | Radiology | QIH |
10/25/2024 | K243189 | TumorSight Viz | SimBioSys, Inc. | Radiology | QIH |
10/25/2024 | K242215 | Neurophet AQUA (V3.1) | Neurophet, Inc. | Radiology | QIH |
10/22/2024 | K243209 | nordicMEDiVA | NordicNeurolab AS | Radiology | LLZ |
10/18/2024 | K242837 | BriefCase-Triage | Aidoc Medical, Ltd. | Radiology | QAS |
10/18/2024 | K241490 | Contour+ (MVision AI Segmentation) | MVision AI Oy | Radiology | QKB |
10/17/2024 | K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc | Neurology | OMB |
10/17/2024 | K241242 | SIGNA MAGNUS | GE Medical Systems, LLC | Radiology | LNH |
10/16/2024 | K241481 | xvision Spine System | Augmedics Ltd. | Neurology | SBF |
10/15/2024 | K242781 | cvi42 Software Application | Circle Cardiovascular Ima | Radiology | QIH |
10/11/2024 | K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
10/10/2024 | K241430 | EchoMeasure | iCardio.ai | Radiology | QIH |
10/09/2024 | K241837 | Limbus Contour | Limbus AI Inc. | Radiology | QKB |
10/07/2024 | K240980 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
10/07/2024 | K241029 | SpineUs™ System | Verdure Imaging | Radiology | IYO |
10/04/2024 | K240553 | LVivo Software Application | DiA Imaging Analysis Ltd. | Radiology | QIH |
10/04/2024 | K242652 | Lunit INSIGHT DBT v1.1 | Lunit Inc. | Radiology | QDQ |
10/04/2024 | K241245 | EchoSolv AS | Echo IQ Ltd | Radiology | POK |
10/02/2024 | K241561 | MammoScreen BD | Therapixel | Radiology | QIH |
10/02/2024 | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | GE Medical Systems Ultr | Radiology | IYN |
10/01/2024 | K240943 | LungVision | BodyVision Medical Ltd. | Radiology | QIH |
10/01/2024 | K241331 | MuscleView | Springbok, Inc. | Radiology | LNH |
09/27/2024 | K241480 | JBS-LVO | JLK, Inc. | Radiology | QAS |
09/27/2024 | K240369 | CAC (gated) Algorithm | BunkerHill Health | Radiology | JAK |
09/27/2024 | K240993 | encevis (2.1) | AIT Austrian Institute of | Neurology | OMB |
09/24/2024 | K242292 | uAI Easy Triage ICH | Shanghai United Imaging | Radiology | QAS |
09/23/2024 | P140011/S008 | MAMMOMAT B.brilliant with Tomosynthesis Option | SIEMENS MEDICAL SOLUT | Radiology | OTE |
09/23/2024 | K240013 | EchoGo Heart Failure (2.0) | Ultromics Limited | Cardiovascular | QUO |
09/20/2024 | K240036 | PIUR tUS Infinity | PIUR Imaging GmbH | Radiology | QIH |
09/13/2024 | K240929 | Sleep Apnea Notification Feature (SANF) | Apple Inc. | Anesthesiology | QZW |
09/12/2024 | K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Canon Medical Systems | Radiology | IYN |
09/12/2024 | K241280 | Constellation (CON-001) | Q Bio, Inc. | Radiology | QIH |
09/12/2024 | K240942 | CINA-CSpine | Avicenna.AI | Radiology | QAS |
09/11/2024 | K241380 | FETOLY-HEART | Diagnoly | Radiology | IYN |
09/10/2024 | K240094 | LumiNE US; Lumi | Augmedit B.V. | Radiology | QIH |
09/09/2024 | K241681 | Overjet Image Enhancement Assist | Overjet Inc | Radiology | QIH |
09/09/2024 | K240791 | ADAS 3D | Adas3D Medical S.L | Radiology | QIH |
09/09/2024 | K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies | Radiology | QDQ |
09/06/2024 | K240411 | uAI Portal | Shanghai United Imaging | Radiology | QIH |
09/05/2024 | K233998 | TRAQinform IQ | AIQ Global, Inc. | Radiology | LLZ |
09/04/2024 | K233977 | Velacur | Sonic Incytes | Radiology | IYO |
08/30/2024 | K240003 | Velmeni for Dentists (V4D) | Velmeni Inc. | Radiology | MYN |
08/30/2024 | K241847 | Imbio PHA (4.0.0) | Imbio, Inc | Radiology | QIH |
08/30/2024 | K241585 | uMI Panorama | Shanghai United Imaging | Radiology | KPS |
08/30/2024 | K242300 | MI View&GO | Siemens Medical Solutio | Radiology | QIH |
08/30/2024 | K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutio | Radiology | QIH |
08/29/2024 | K233826 | Kosmos | EchoNous, Inc. | Radiology | IYN |
08/27/2024 | K241684 | Overjet Charting Assist | Overjet, Inc | Radiology | QIH |
08/22/2024 | K241098 | NeuroQuant | CorTechs Labs, Inc. | Radiology | QIH |
08/21/2024 | K240290 | AiMIFY (1.x) | Subtle Medical, Inc. | Radiology | LLZ |
08/20/2024 | K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | Procept BioRobotics | General and Plastic Surgery | PZP |
08/20/2024 | K241496 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
08/19/2024 | K241440 | HealthCCSng | Nano-X AI Ltd. | Radiology | JAK |
08/16/2024 | K233755 | HeartKey® Rhythm | B-Secur Limited | Cardiovascular | DQK |
08/16/2024 | K240740 | qCT LN Quant | Qure.ai Technologies | Radiology | QIH |
08/15/2024 | K241211 | CoLumbo | Smart Soft Healthcare | Radiology | QIH |
08/15/2024 | K241596 | uMI Panvivo | Shanghai United Imaging | Radiology | KPS |
08/13/2024 | K241429 | ECHELON Synergy MRI System | FUJIFILM Healthcare Cor | Radiology | LNH |
08/12/2024 | K242054 | OptimMRI (v2) | Rebrain, SAS | Radiology | QIH |
08/08/2024 | K241665 | Omni Legend | GE Medical Systems Isra | Radiology | KPS |
08/08/2024 | K233822 | i2Contour | MRIMath LLC | Radiology | QIH |
08/05/2024 | K240953 | AI Platform 2.0 (AIP002) | Exo Imaging | Radiology | QIH |
08/05/2024 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty Ltd | Orthopedic | QHE |
08/02/2024 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LL | Cardiovascular | QMS |
08/01/2024 | K234141 | AISAP Cardio V1.0 | Aisap | Radiology | POK |
08/01/2024 | K240301 | MammoScreen® (3) | Therapixel | Radiology | QDQ |
08/01/2024 | K233731 | CardIQ Suite | GE Medical Systems SCS | Radiology | JAK |
07/25/2024 | K241887 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM30 | Cosmo Artificial Intellige | Gastroenterology-Urology | QNP |
07/24/2024 | K240044 | CADDIE | Odin Medical Limited | Gastroenterology-Urology | QNP |
07/22/2024 | K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic U | Siemens Medical Solutio | Radiology | IYN |
07/17/2024 | K241121 | MICSI-RMT | Microstructure Imaging, I | Radiology | LLZ |
07/17/2024 | K240845 | Rayvolve | AZmed SAS | Radiology | QBS |
07/16/2024 | K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | Radiology | LNH |
07/15/2024 | K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | Anesthesiology | MNR |
07/12/2024 | K233457 | RUS | Hutom Inc. | Radiology | QIH |
07/12/2024 | K241727 | BriefCase-Triage | Aidoc Medical, Ltd. | Radiology | QAS |
07/12/2024 | K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Radiology | QIH |
07/11/2024 | K241329 | SubtleSYNTH (1.x) | Subtle Medical, Inc. | Radiology | QIH |
07/03/2024 | K241508 | SKOUT® system | Iterative Scopes, Inc. | Gastroenterology-Urology | QNP |
07/02/2024 | K240736 | SMART Bun-Yo-Matic X-Ray | Disior Ltd | Radiology | QIH |
07/02/2024 | K240555 | Tyto Insights for Crackles Detection | Tyto Care Ltd. | Anesthesiology | PHZ |
07/01/2024 | K240353 | Hyper Insight - ICH | SK Inc. | Radiology | QAS |
06/25/2024 | K240582 | VEA Align; spineEOS | EOS imaging | Radiology | QIH |
06/21/2024 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | AgileMD, Inc. | Cardiovascular | QNL |
06/21/2024 | K240465 | O-arm O2 Imaging System | Medtronic Navigation, In | Radiology | OWB |
06/21/2024 | K233549 | Tempus ECG-AF | Tempus AI, Inc. | Cardiovascular | SBQ |
06/21/2024 | K233196 | Medihub Prostate | JLK Inc. | Radiology | QIH |
06/21/2024 | K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
06/20/2024 | K240642 | SMART Bun-Yo-Matic CT | Disior Ltd | Radiology | QIH |
06/14/2024 | K233955 | Clarius OB AI | Clarius Mobile Health Co | Radiology | IYN |
06/14/2024 | K241083 | SIS System | Surgical Information Scie | Radiology | QIH |
06/13/2024 | K233925 | Relu Creator | Relu BV | Radiology | QIH |
06/13/2024 | K233662 | Radiography 7300 C | Philips Medical Systems | Radiology | KPR |
06/12/2024 | K240516 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
06/07/2024 | K232035 | Impala | AliveCor, Inc. | Cardiovascular | DPS |
06/07/2024 | K231010 | Corvair | AliveCor, Inc. | Cardiovascular | MHX |
06/07/2024 | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.AI Co., Ltd. | Radiology | QIH |
06/07/2024 | K241038 | Cardiac CT Function Software Application | Circle Cardiovascular Ima | Radiology | QIH |
05/31/2024 | K240612 | CINA-VCF | Avicenna.AI | Radiology | QFM |
05/24/2024 | K234154 | uPMR 790 | Shanghai United Imaging | Radiology | OUO |
05/24/2024 | K240769 | LVivo IQS | DiA Imaging Analysis Ltd. | Radiology | QIH |
05/23/2024 | K233108 | VinDr-Mammo | VinBigData Joint Stock C | Radiology | QFM |
05/23/2024 | K240294 | Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare Gm | Radiology | LLZ |
05/21/2024 | K233543 | YSIO X.pree | Siemens Medical Solutio | Radiology | KPR |
05/17/2024 | DEN230035 | DentalMonitoring | Dental Monitoring SAS | Dental | SBC |
05/17/2024 | K233209 | uOmnispace.CT | Shanghai United Imaging | Radiology | QIH |
05/16/2024 | K233625 | RAYDENT SW | RAY Co., Ltd. | Dental | PNN |
05/15/2024 | K233247 | Heuron ICH | Heuron Co., Ltd. | Radiology | QAS |
05/15/2024 | K241112 | BriefCase-Quantification | Aidoc Medical, Ltd. | Radiology | QIH |
05/15/2024 | DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision Inc | Ophthalmic | SAX |
05/10/2024 | K232410 | SmartChest | Milvue | Radiology | QFM |
05/07/2024 | K232928 | DeepContour (V1.0) | Wisdom Technologies., I | Radiology | QKB |
05/07/2024 | K233864 | ASSURE Wearable ECG | Kestra Medical Technolo | Cardiovascular | MWJ |
05/03/2024 | K232491 | CT 5300 | Philips Healthcare (Suzh | Radiology | JAK |
05/03/2024 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray Inc. | Hematology | LKM |
05/03/2024 | K233687 | ECHELON Synergy V10.0 | Fujifilm Healthcare Ame | Radiology | LNH |
04/30/2024 | K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems I | Radiology | IYE |
04/29/2024 | K240062 | ARVIS® Shoulder | Insight Medical Systems, | Neurology | OLO |
04/26/2024 | K232799 | syngo.via RT Image Suite | Siemens Medical Solutio | Radiology | MUJ |
04/26/2024 | K240406 | Sonio Detect | Sonio | Radiology | IYN |
04/26/2024 | K233673 | uMR Jupiter | Shanghai United Imaging | Radiology | LNH |
04/25/2024 | K232331 | InVision Precision LVEF (LVEF) | InVision Medical Techno | Radiology | QIH |
04/24/2024 | K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound LLC | Radiology | IYN |
04/23/2024 | K240058 | AEYE-DS | AEYE Health Inc. | Ophthalmic | PIB |
04/22/2024 | K234068 | ART-Plan (v.2.2.0) | Therapanacea SAS | Radiology | MUJ |
04/22/2024 | K233582 | Rapid | iSchema View Inc. | Radiology | LLZ |
04/19/2024 | K240781 | SKOUT® system | Iterative Scopes, Inc. | Gastroenterology-Urology | QNP |
04/17/2024 | K233186 | uOmnispace.MR | Shanghai United Imaging | Radiology | QIH |
04/15/2024 | K240773 | VisAble.IO | Techsomed | Radiology | QTZ |
04/12/2024 | K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
04/11/2024 | K233698 | True Enhance DL | GE Healthcare Japan Cor | Radiology | JAK |
04/10/2024 | K240744 | uMR 680 | Shanghai United Imaging | Radiology | LNH |
04/09/2024 | DEN230023 | Rho | 16 Bit Inc | Radiology | SAO |
04/08/2024 | K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.AI, Co., Ltd. | Radiology | QAS |
04/05/2024 | K233249 | APPRAISE-HRI | The Surgeon General, De | Cardiovascular | SAR |
04/05/2024 | K233666 | CorVista System with PH Add-On | Analytics for Life, Inc. | Cardiovascular | SAT |
04/04/2024 | K240172 | Preview Shoulder | Genesis Software Innova | Radiology | QIH |
04/03/2024 | K233618 | Oxevision Sleep Device | Oxehealth Limited | Neurology | LEL |
04/03/2024 | K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutio | Radiology | QKB |
04/02/2024 | DEN230036 | Sepsis ImmunoScore | Prenosis, Inc. | General Hospital | SAK |
04/02/2024 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems | Radiology | JAK |
04/01/2024 | K233676 | Us2.v2 | Eko.ai Pte. Ltd d/b/a Us2. | Radiology | QIH |
03/29/2024 | K233211 | AVIEW CAC | Coreline Soft Co., Ltd. | Radiology | QIH |
03/28/2024 | K233657 | NAEOTOM Alpha | Siemens Medical Solutio | Radiology | JAK |
03/28/2024 | K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | Cardiovascular | QYE |
03/26/2024 | K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM | Siemens Medical Solutio | Radiology | JAK |
03/22/2024 | K240540 | uMR Omega | Shanghai United Imaging | Radiology | LNH |
03/22/2024 | K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutio | Radiology | QAS |
03/22/2024 | K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutio | Radiology | LNH |
03/21/2024 | K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare Gm | Radiology | JAK |
03/20/2024 | K234047 | Automatic Registration | Brainlab AG | Neurology | OLO |
03/15/2024 | K233342 | CINA-ASPECTS | Avicenna.AI | Radiology | POK |
03/13/2024 | K233968 | CINA-iPE | Avicenna.AI | Radiology | QAS |
03/11/2024 | K232140 | OTS Hip | Ortoma AB | Neurology | OLO |
03/08/2024 | K233438 | SleepStageML | Beacon Biosignals, Inc. | Neurology | OLZ |
03/07/2024 | K233692 | Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultr | Radiology | IYN |
03/06/2024 | K231677 | EdgeFlow UH10 | Edgecare Inc. | Radiology | IYO |
03/04/2024 | K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc | Radiology | MYN |
03/01/2024 | K231690 | iCAS-LV | HighRAD Ltd. | Radiology | QIH |
03/01/2024 | K233030 | BoneMRI | MRIguidance B.V | Radiology | QIH |
02/29/2024 | K232765 | MAGNETOM Cima.X Fit | Siemens Medical Solutio | Radiology | LNH |
02/29/2024 | K231683 | inHEART Models | inHEART, SAS | Radiology | QIH |
02/28/2024 | K232613 | CT Cardiomegaly | Innolitics, LLC | Radiology | QIH |
02/23/2024 | K233590 | Overjet Charting Assist | Overjet, Inc | Radiology | QIH |
02/22/2024 | K233749 | Revolution Ascend Sliding | GE Hangwei Medical Syst | Radiology | JAK |
02/21/2024 | K232148 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Dental | QRY |
02/15/2024 | K232915 | EpiMonitor | Empatica Srl | Neurology | POS |
02/13/2024 | K231855 | QOCA® image Smart RT Contouring System | Quanta Computer Inc. | Radiology | QKB |
02/13/2024 | K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
02/09/2024 | K231355 | Aurora | EnsoData | Anesthesiology | MNR |
02/08/2024 | K233080 | HealthFLD | Nano-X AI Ltd. | Radiology | JAK |
02/06/2024 | DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., | Anesthesiology | QZW |
02/05/2024 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz.ai, Inc. | Radiology | QIH |
01/31/2024 | DEN210035 | “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” | Hologic Inc. | Pathology | QYV |
01/31/2024 | K231396 | CEPHX- Cephalometric Analysis Software | Orca Dental AI LTD | Radiology | LLZ |
01/24/2024 | K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Canon Medical Systems | Radiology | IYN |
01/19/2024 | K232156 | Rapid ASPECTS (v3) | iSchemaView, Inc. | Radiology | POK |
01/19/2024 | K233728 | SIGNA Champion | GE Healthcare (Tianjin) C | Radiology | LNH |
01/18/2024 | K232698 | NemoScan | Software Nemotec S.L. | Radiology | QIH |
01/17/2024 | K231871 | Radify Triage | Envisionit DeepAI Ltd | Radiology | QFM |
01/16/2024 | K233512 | Rapid (6.0) | iSchemaView, Inc. | Radiology | QIH |
01/13/2024 | K233216 | CLEWICU System | Clew Medical Ltd. | Cardiovascular | QNL |
01/12/2024 | K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) | Cosmo Artificial Intellige | Gastroenterology-Urology | QNP |
01/12/2024 | DEN220040 | Fibresolve | Imvaria, Inc | Radiology | QWO |
01/12/2024 | K233677 | Biograph VK10 | Siemens Medical Solutio | Radiology | KPS |
01/12/2024 | DEN230008 | DermaSensor | DermaSensor Inc. | General and Plastic Surgery | QZS |
01/11/2024 | K232250 | SurgiCount+ System | Stryker Instruments | General Hospital | PBZ |
01/11/2024 | DEN220066 | BrainSee | Darmiyan, Inc. | Neurology | QWT |
01/08/2024 | K232412 | LungQ v3.0.0 | Thirona BV | Radiology | JAK |
01/08/2024 | K231324 | DASI Dimensions (V1.0) | DASI Simulations | Radiology | QIH |
01/07/2024 | K231068 | autoSCORE | Holberg EEG AS | Neurology | OMB |
01/05/2024 | K231917 | VEA Align | EOS imaging | Radiology | QIH |
01/04/2024 | K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | Radiology | IYN |
01/03/2024 | K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | Neurology | OMB |
12/26/2023 | K231130 | TumorSight Viz | SimBioSys, Inc. | Radiology | QIH |
12/22/2023 | K231805 | qXR-LN | Qure.ai Technologies | Radiology | MYN |
12/22/2023 | K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutio | Radiology | LNH |
12/22/2023 | K232479 | ART-Plan | TheraPanacea | Radiology | MUJ |
12/21/2023 | K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison CO., L | Radiology | IYN |
12/20/2023 | K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | Orthopedic | OOG |
12/20/2023 | K233176 | uOmnispace.MI | Shanghai United Imaging | Radiology | LLZ |
12/18/2023 | K231929 | iQ-solutions | Sydney Neuroimaging A | Radiology | QIH |
12/18/2023 | K231587 | MAGNETOM Cima.X | Siemens Medical Solutio | Radiology | LNH |
12/15/2023 | K230751 | EW10-EC02 Endoscopy Support Program | FUJIFILM Corporation | Gastroenterology-Urology | QNP |
12/15/2023 | K232384 | Videa Dental Assist | VideaHealth, Inc. | Radiology | MYN |
12/14/2023 | K231570 | StrokeViewer Perfusion | NICo-Lab B.V. | Radiology | LLZ |
12/13/2023 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care Ltd. | Anesthesiology | PHZ |
12/13/2023 | K232231 | QP-Brain® | Quibim S.L. | Radiology | QIH |
12/12/2023 | DEN230027 | NaviCam ProScan | Ankon Technologies c | Gastroenterology/Urology | QZF |
12/11/2023 | K232096 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | Radiology | QIH |
12/08/2023 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | Radiology | LLZ |
12/08/2023 | K223757 | Bonelogic | Disior Ltd | Radiology | LLZ |
12/07/2023 | K232661 | Myocardial Strain Software Application | Circle Cardiovascular Ima | Radiology | LLZ |
12/07/2023 | K232381 | LOGIQ Totus | GE Medical Systems Ultr | Radiology | IYN |
12/06/2023 | K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems | Radiology | JAK |
12/06/2023 | K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Cardiovascular | MXD |
12/05/2023 | K232440 | Adravision Perio | Adra Corporation | Radiology | QIH |
12/05/2023 | K233568 | Ceevra Reveal 3+ | Ceevra, Inc. | Radiology | QIH |
12/01/2023 | K232856 | Syngo Carbon Clinicals | Siemens Healthcare Gm | Radiology | QIH |
11/30/2023 | K233545 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
11/29/2023 | K230179 | 6440 MyLabX90 | Esaote S.p.A. | Radiology | IYN |
11/28/2023 | K231631 | BriefCase-Quantification | Aidoc Medical, Ltd. | Radiology | JAK |
11/28/2023 | K232000 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutio | Radiology | QIH |
11/27/2023 | K233243 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro Inc. | Neurology | HAW |
11/21/2023 | K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | Radiology | QAS |
11/17/2023 | K232501 | AI Platform (AIP001) | Exo Inc | Radiology | QIH |
11/15/2023 | K232841 | Axial3D Insight | Axial Medical Printing Li | Radiology | QIH |
11/14/2023 | K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutio | Radiology | LNH |
11/13/2023 | K232083 | BriefCase-Quantification | Aidoc Medical, Ltd. | Radiology | QIH |
11/13/2023 | K232257 | Clarius Bladder AI | Clarius Mobile Health Co | Radiology | QIH |
11/09/2023 | K223754 | BraveCX | Bering Ltd | Radiology | QFM |
11/09/2023 | K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Medical Solutio | Radiology | LNH |
11/08/2023 | K231765 | Contour ProtégéAI | MIM Software Inc. | Radiology | QKB |
11/08/2023 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | Radiology | QIH |
11/07/2023 | K231989 | LOGIQ E10s, LOGIQ Fortis | GE Medical Systems Ultr | Radiology | IYN |
11/07/2023 | K231966 | LOGIQ E10 | GE Medical Systems Ultr | Radiology | IYN |
11/06/2023 | K231470 | Lunit INSIGHT DBT | Lunit Inc. | Radiology | QDQ |
11/03/2023 | K231955 | aprevo® Digital Segmentation | Carlsmed, Inc. | Radiology | QIH |
10/30/2023 | K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultr | Radiology | IYN |
10/30/2023 | K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic U | Siemens Medical Solutio | Radiology | IYN |
10/30/2023 | K232751 | BriefCase-Triage | Aidoc Medical, Ltd. | Radiology | QAS |
10/27/2023 | K230854 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
10/27/2023 | K232045 | MeVis Liver Suite | MeVis Medical Solutions | Radiology | JAK |
10/26/2023 | K232500 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | Radiology | IYN |
10/25/2023 | K232436 | Rapid SDH | iSchemaView, Inc. | Radiology | QAS |
10/25/2023 | K230842 | SignalHF (IM008) | Implicity Inc. | Cardiovascular | QNL |
10/23/2023 | K231764 | Ultrasound System 1300 | BK Medical Aps | Radiology | IYN |
10/23/2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutio | Radiology | LNH |
10/23/2023 | K232305 | AI-Rad Companion Brain MR | Siemens Medical Solutio | Radiology | QIH |
10/20/2023 | K230209 | Sonix Health | Ontact Health Co., Ltd. | Radiology | QIH |
10/13/2023 | K230370 | SpotLight/SpotLight Duo (with DLIR option) | Arineta Ltd. | Radiology | JAK |
10/13/2023 | K231642 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | Radiology | LLZ |
10/11/2023 | K230220 | NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical System | Radiology | JAK |
10/06/2023 | K223905 | Vivio® LVEDP System | Avicena, LLC | Cardiovascular | QUO |
10/06/2023 | K230144 | Denti.AI Detect | Denti.AI Technology, Inc. | Radiology | MYN |
10/06/2023 | K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | Radiology | LNH |
10/06/2023 | K232787 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Li | Anesthesiology | QRG |
10/05/2023 | K232367 | cmAngio® V1.0 | CureMetrix, Inc. | Radiology | QIH |
10/05/2023 | K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Co | Radiology | IYN |
10/05/2023 | K231001 | DeepTek CXR Analyzer v1.0 | DeepTek Medical Imagin | Radiology | MYN |
10/04/2023 | K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.AI Co., Ltd. | Radiology | QAS |
10/04/2023 | K231398 | VUNO Med-DeepBrain | VUNO Inc. | Radiology | QIH |
10/04/2023 | K232023 | Momentum Spine | Momentum Health Inc. | Radiology | LDK |
10/03/2023 | K230085 | Lung-CAD | Imagen Technologies, In | Radiology | MYN |
10/03/2023 | K232712 | uMI Panorama | Shanghai United Imaging | Radiology | KPS |
10/03/2023 | K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
09/29/2023 | K230045 | HipCheck | Stryker Corp. | Radiology | QIH |
09/28/2023 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | Cardiovascular | QYE |
09/28/2023 | K231837 | Brainomix 360 Triage LVO | Brainomix Limited | Radiology | QAS |
09/27/2023 | K232616 | Volta AF-Xplorer | Volta Medical | Cardiovascular | DQK |
09/26/2023 | K230252 | OFIX MIS App | Orthofix US LLC | Radiology | LLZ |
09/25/2023 | K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.AI Co., Ltd. | Radiology | QKB |
09/22/2023 | K231149 | qXR-CTR | Qure.ai Technologies | Radiology | QIH |
09/22/2023 | K231767 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd | Radiology | QAS |
09/22/2023 | K223659 | Jazz | AI Medical AG | Radiology | LLZ |
09/22/2023 | K231384 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd. | Radiology | QAS |
09/21/2023 | K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc | Radiology | MYN |
09/19/2023 | K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems | Radiology | JAK |
09/19/2023 | K221309 | AI100 with Shonit | SigTuple Technologies P | Hematology | JOY |
09/14/2023 | K220034 | NEUROShield | In-Med Prognostics L3C | Radiology | LLZ |
09/13/2023 | K223811 | Lung-CAD | Imagen Technologies, In | Radiology | MYN |
09/12/2023 | K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems | Radiology | JAA |
09/12/2023 | K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems | Radiology | KPS |
09/09/2023 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEE | Brainlab AG | Neurology | HAW |
09/08/2023 | K223621 | DeepXray | Alpha Intelligence Manif | Radiology | QIH |
09/08/2023 | K222921 | Minuteful-kidney test | Healthy.io Ltd. | Clinical Chemistry | JIR |
09/08/2023 | K232686 | CorVista® System | CorVista Health, Inc. | Cardiovascular | QXX |
09/08/2023 | K231335 | Cleerly ISCHEMIA | Cleerly, Inc | Cardiovascular | QXZ |
09/07/2023 | K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster, Inc. | Cardiovascular | DQK |
09/06/2023 | K232482 | MAGNETOM Viato.Mobile | Siemens Medical Solutio | Radiology | LNH |
09/01/2023 | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | FaceHeart Corp. | Cardiovascular | QME |
08/30/2023 | K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
08/28/2023 | K223639 | VisAble.IO | TechsoMed | Radiology | QTZ |
08/25/2023 | K223180 | AIRAscore | AIRAmed GmbH | Radiology | LLZ |
08/23/2023 | K230812 | Withings Scan Monitor 2.0 | Withings | Cardiovascular | DPS |
08/22/2023 | K230899 | qXR-PTX-PE | Qure.ai Technologies | Radiology | QFM |
08/18/2023 | K223539 | Dreem 3S | Beacon Biosignals, Inc. | Neurology | OLZ |
08/15/2023 | K231094 | Annalise Enterprise CTB Triage-OH | Annalise-AI Pty Ltd | Radiology | QAS |
08/03/2023 | DEN230003 | Viz HCM | Viz.ai, Inc. | Cardiovascular | QXO |
08/03/2023 | K223133 | VisiRad XR | Imidex Inc. | Radiology | MYN |
08/02/2023 | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG | Neurology | OLO |
07/27/2023 | K230074 | Rapid Aneurysm Triage and Notification | iSchemaView Inc. | Radiology | QFM |
07/27/2023 | K231195 | Brainomix 360 Triage ICH | Brainomix Limited | Radiology | QAS |
07/26/2023 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LL | Cardiovascular | QNL |
07/26/2023 | K231572 | uMI Panorama | Shanghai United Imaging | Radiology | KPS |
07/25/2023 | K230365 | Sonio Detect | Sonio | Radiology | IYN |
07/25/2023 | K223473 | ME-APDS™; MAGENTIQ-COLO™ | Magentiq Eye LTD | Gastroenterology-Urology | QNP |
07/25/2023 | K230913 | ANDI | Imeka Solutions, Inc. | Radiology | QIH |
07/24/2023 | K223347 | UltraSight AI Guidance | UltraSight Inc. | Radiology | QJU |
07/21/2023 | K230150 | OptimMRI | RebrAIn, SAS | Radiology | QIH |
07/21/2023 | K231173 | Irregular Rhythm Notification Feature (IRNF) | Apple Inc. | Cardiovascular | QDB |
07/21/2023 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | Neurology | HAW |
07/20/2023 | K230039 | uOmnispace | Shanghai United Imaging | Radiology | QIH |
07/19/2023 | K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare Gm | Radiology | OEB |
07/14/2023 | K231757 | Ez3D-i /E3 | Ewoosoft Co., Ltd | Radiology | QIH |
07/14/2023 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angi | Brainlab AG | Radiology | QIH |
07/13/2023 | K223424 | Spine Auto Views | GE Medical Systems SCS | Radiology | JAK |
07/13/2023 | K231833 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutio | Radiology | KPS |
07/13/2023 | K223426 | ECHELON Synergy MRI system | FUJIFILM Healthcare Cor | Radiology | LNH |
07/12/2023 | K230823 | AusculThing ACC | AusculThing Oy | Cardiovascular | DQD |
07/10/2023 | K223724 | MOZI TPS | Manteia Technologies C | Radiology | MUJ |
07/07/2023 | K231668 | Spine CAMP™ (1.1) | Medical Metrics, Inc. | Radiology | QIH |
07/03/2023 | K222745 | Axial3D Insight | Axial Medical Printing Li | Radiology | QIH |
06/29/2023 | DEN200052 | KidneyIntelX.dkd | Renalytix AI, Inc. | Clinical Chemistry | QWZ |
06/29/2023 | K230337 | EarliPoint | EarliTec Diagnostics, Inc | Neurology | QPF |
06/22/2023 | K230497 | Bladder AI (AIBV01) | Exo Inc | Radiology | QIH |
06/20/2023 | K230346 | Voluson SWIFT; Voluson SWIFT+ | GE Medical Systems Ultr | Radiology | IYN |
06/20/2023 | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analy | Radiology | LNH |
06/16/2023 | K223646 | IB Lab LAMA | IB Lab GmbH | Radiology | QIH |
06/16/2023 | K223556 | DeepCatch | MEDICALIP Co., Ltd | Radiology | QIH |
06/16/2023 | K223357 | EyeArt v2.2.0 | Eyenuk, Inc. | Ophthalmic | PIB |
06/13/2023 | K230112 | CAC Software | Imbio, Inc. | Radiology | JAK |
06/06/2023 | K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | FEops nv | Radiology | QIH |
05/30/2023 | K223523 | Sonic DL | GE Medical Systems,LLC ( | Radiology | LNH |
05/25/2023 | K230273 | Saranas Early Bird Bleed Monitoring System | Saranas Inc. | Cardiovascular | QFJ |
05/25/2023 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | GE Medical Systems, LLC | Radiology | QBS |
05/23/2023 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | Radiology | QDQ |
05/23/2023 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | Neurology | OMB |
05/19/2023 | K212758 | Autoplaque | Cedars-Sinai Medical Ce | Radiology | LLZ |
05/19/2023 | K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intellige | Gastroenterology-Urology | QNP |
05/17/2023 | K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD | Radiology | MUJ |
05/12/2023 | K231190 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound LLC | Radiology | IYN |
05/11/2023 | K223623 | SubtleMR (2.3.x) | Subtle Medical Inc. | Radiology | LLZ |
05/10/2023 | K220437 | Neurophet AQUA | NEUROPHET, Inc. | Radiology | LLZ |
05/04/2023 | K223771 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | Radiology | IYN |
05/04/2023 | K230082 | Auto Segmentation | GE Medical Systems, LLC | Radiology | QKB |
05/02/2023 | K230977 | SIS System | Surgical Information Scie | Radiology | QIH |
05/02/2023 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., | Cardiovascular | QDA |
04/28/2023 | P210011 | xT CDx | Tempus Labs, Inc. | Pathology | PQP |
04/27/2023 | K223212 | Precision DL | GE Healthcare | Radiology | KPS |
04/27/2023 | K223734 | ENT EM | Brainlab AG | Neurology | PGW |
04/26/2023 | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | Cardiovascular | MXD |
04/26/2023 | K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | Radiology | LLZ |
04/25/2023 | K230223 | iCAC Device | Bunkerhill, Inc | Radiology | JAK |
04/25/2023 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | Radiology | QIH |
04/21/2023 | K223501 | ViewFinder Software Version 1.1 | Elaitra Ltd | Radiology | QIH |
04/21/2023 | K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison CO., L | Radiology | IYN |
04/20/2023 | K230807 | Deep Learning Image Reconstruction | GE Healthcare Japan Cor | Radiology | JAK |
04/20/2023 | K223287 | Velacur | Sonic Incytes | Radiology | IYO |
04/19/2023 | K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | Neurology | HAW |
04/19/2023 | K230023 | ART-Plan | Therapanacea SAS | Radiology | QKB |
04/17/2023 | K230772 | Quantib Prostate | Quantib BV | Radiology | LLZ |
04/14/2023 | K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | Radiology | QKB |
04/13/2023 | K230264 | Ezra Flash | Ezra AI, Inc. | Radiology | LLZ |
04/13/2023 | K213986 | CerebralGo Plus | Yukun (Beijing) Technolo | Radiology | QIH |
04/11/2023 | K223830 | Ultrasound System 2300 | BK Medical Aps | Radiology | IYN |
04/07/2023 | K230575 | Limbus Contour | Limbus AI Inc. | Radiology | LLZ |
04/07/2023 | K230658 | SKOUT® system | Iterative Scopes Inc. | Gastroenterology-Urology | QNP |
04/06/2023 | K223774 | Contour ProtégéAI | MIM Software Inc. | Radiology | QKB |
04/06/2023 | K222360 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutio | Radiology | JAK |
04/06/2023 | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | Philips Medical Systems | Radiology | LNH |
04/05/2023 | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | Cardiovascular | MXD |
04/03/2023 | K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd | Radiology | QAS |
03/31/2023 | K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | Radiology | IYO |
03/31/2023 | K213272 | Formus Hip | Formus Labs, Ltd | Radiology | QIH |
03/31/2023 | DEN200011 | Masimo SafetyNet | Masimo Corporation | Anesthesiology | QVT |
03/29/2023 | K222312 | RayStation 12A | RaySearch Laboratories | Radiology | MUJ |
03/28/2023 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | Radiology | MYN |
03/28/2023 | K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-AI Pty Ltd | Radiology | QFM |
03/28/2023 | K222174 | RadioLens v1.0 | Synapsica | Radiology | QIH |
03/28/2023 | K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-AI Pty Ltd | Radiology | QFM |
03/28/2023 | K223343 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutio | Radiology | LNH |
03/27/2023 | K222746 | Overjet Caries Assist | Overjet, Inc. | Radiology | MYN |
03/22/2023 | K222036 | MPXA-2000 | Medipixel, Inc. | Radiology | QIH |
03/21/2023 | K223490 | FlightPlan for Embolization | GE Medical Systems SCS | Radiology | LLZ |
03/17/2023 | K221772 | NeuroRPM | New Touch Digital Inc. | Neurology | GYD |
03/17/2023 | K223443 | Viz AAA | Viz. ai, Inc. | Radiology | QFM |
03/17/2023 | K223073 | Alio | Alio, Inc. | Cardiovascular | DRG |
03/10/2023 | K223325 | uMI Panorama | Shanghai United Imaging | Radiology | KPS |
03/09/2023 | K223514 | Spectral Bone Marrow | GE Medical Systems, LLC | Radiology | JAK |
03/09/2023 | K221706 | AccuContour | Manteia Technologies C | Radiology | QKB |
03/07/2023 | K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems | Radiology | JAK |
03/03/2023 | K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems | Radiology | JAK |
03/02/2023 | K222176 | BoneView | Gleamer | Radiology | QBS |
03/02/2023 | K222884 | Rapid NCCT Stroke | iSchemaView, Inc. | Radiology | QAS |
03/01/2023 | K221680 | Xeleris V Processing and Review System | GE Healthcare | Radiology | LLZ |
02/24/2023 | K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co.,Ltd. | Radiology | OEB |
02/24/2023 | DEN220063 | Caption Interpretation Automated Ejection Fraction Software | Caption Health, Inc | Radiology | QVD |
02/23/2023 | K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | Radiology | POK |
02/23/2023 | K222579 | Belun Sleep System BLS-100 | Belun Technology Comp | Anesthesiology | MNR |
02/22/2023 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | Radiology | LNH |
02/22/2023 | K230197 | BoneMRI v1.6 | MRIguidance B.V. | Radiology | QIH |
02/17/2023 | DEN210022 | PMD-200 | Medasense Biometrics Lt | Anesthesiology | QVE |
02/16/2023 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging | Radiology | JAK |
02/16/2023 | K222755 | uMR 680 | Shanghai United Imaging | Radiology | LNH |
02/15/2023 | K222389 | ZEUS System | iRhythm Technologies, I | Cardiovascular | DQK |
02/13/2023 | K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
02/13/2023 | K223439 | SIGNA Victor | GE Healthcare (Tianjin) C | Radiology | LNH |
02/06/2023 | K223296 | Videa Perio Assist | VideaHealth, Inc. | Radiology | QIH |
02/02/2023 | K222803 | Oncospace | Oncospace, Inc. | Radiology | MUJ |
02/01/2023 | K230020 | BriefCase | Aidoc Medical, Ltd. | Radiology | QFM |
02/01/2023 | K222970 | LVivo IQS | DiA Imaging Analysis Ltd | Radiology | QIH |
02/01/2023 | K223396 | Rapid RV/LV | iSchema View Inc. | Radiology | QIH |
01/27/2023 | K221868 | QOCA image Smart CXR Image Processing System | Quanta Computer Inc. | Radiology | QFM |
01/23/2023 | K222406 | Clarius AI | Clarius Mobile Health Co | Radiology | QIH |
01/21/2023 | K223516 | VX1+ | Volta Medical | Cardiovascular | DQK |
01/18/2023 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Ima | Radiology | LLZ |
01/13/2023 | K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | Radiology | LLZ |
01/12/2023 | K222458 | AIBOLIT 3D+ | Aibolit Technologies, LLC | Radiology | LLZ |
01/11/2023 | K223738 | Alpha Control Liner System (ACLS) | Coapt | Neurology | GXY |
12/23/2022 | K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems | Radiology | LNH |
12/23/2022 | K214036 | AVIEW | Coreline Soft Co.,Ltd. | Radiology | QIH |
12/22/2022 | K223311 | Philips CT 3500 | Philips Healthcare (Suzh | Radiology | JAK |
12/16/2022 | K222275 | Saige-Density | DeepHealth, Inc. | Radiology | QIH |
12/16/2022 | K223268 | BrainInsight | Hyperfine, Inc. | Radiology | QIH |
12/16/2022 | K220928 | Overjet Calculus Assist | Overjet Inc. | Radiology | MYN |
12/06/2022 | K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | Radiology | LNH |
12/05/2022 | K222692 | BriefCase | Aidoc Medical, Ltd. | Radiology | QFM |
12/01/2022 | K220786 | STAR Apollo Mapping System | Rhythm Al, Ltd | Cardiovascular | DQK |
11/22/2022 | K221716 | CINA | AVICENNA.AI | Radiology | QAS |
11/22/2022 | K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | Radiology | POK |
11/21/2022 | K223032 | SIS System (Version 5.6.0) | Surgical Information Scie | Radiology | QIH |
11/18/2022 | K221330 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
11/16/2022 | K221762 | BoneMRI v1.4 | MRlguidance B.V. | Radiology | QIH |
11/14/2022 | K222428 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutio | Radiology | QIH |
11/10/2022 | K221183 | AEYE-DS | AEYE Health, Inc. | Ophthalmic | PIB |
11/10/2022 | K220408 | AVIEW RT ACS | Coreline Soft Co.,Ltd | Radiology | QKB |
11/08/2022 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune AI Co., Ltd. | Radiology | QFM |
10/31/2022 | P210015 | Avive Automated External Defibrillator (AED) System | Avive Solutions, Inc. | Cardiovascular | MKJ |
10/27/2022 | K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging | Radiology | LNH |
10/25/2022 | K222070 | EndoNaut | Therenva SAS | Radiology | OWB |
10/21/2022 | K223042 | Viz LVO ContaCT | Viz.ai, Inc. | Radiology | QAS |
10/20/2022 | K222361 | AI-Rad Companion (Musculoskeletal) | Siemens Medical Solutio | Radiology | JAK |
10/18/2022 | DEN220024 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound L | Anesthesiology | QRG |
10/18/2022 | K221632 | Spine CAMP™ | Medical Metrics, Inc. | Radiology | QIH |
10/14/2022 | K213857 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
10/14/2022 | K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutio | Radiology | QKB |
10/07/2022 | K220709 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
10/06/2022 | K221449 | Genius AI Detection 2.0 | Hologic, Inc. | Radiology | QDQ |
10/05/2022 | K221892 | VISIONAIR | PacificMD Biotech Llc | Anesthesiology | BXQ |
09/30/2022 | K211611 | QIR Suite | CASIS Cardiac Simulation | Radiology | QIH |
09/29/2022 | K220080 | CogNet QmTRIAGE | MedCognetics, Inc. | Radiology | QFM |
09/28/2022 | K222329 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
09/27/2022 | K221738 | NS-HGlio | Neosoma Inc. | Radiology | QIH |
09/21/2022 | K221179 | SomnoMetry | Neumetry Medical Inc | Neurology | OLZ |
09/20/2022 | K213353 | Aorta-CAD | Imagen Technologies, In | Radiology | MYN |
09/13/2022 | K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | Siemens Medical Solutio | Radiology | LNH |
09/12/2022 | K221456 | Rapid ICH | iSchemaView Inc. | Radiology | QAS |
09/12/2022 | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems | Radiology | JAK |
09/08/2022 | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.AI Co., Ltd. | Radiology | QFM |
09/07/2022 | K220783 | syngo.via RT Image Suite | Siemens Medical Solutio | Radiology | MUJ |
09/06/2022 | K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | Radiology | LNH |
09/01/2022 | K221241 | DrAid for Radiology v1 | VinBrain Joint Stock Com | Radiology | QFM |
08/29/2022 | K221100 | Viz RV/LV | Viz.ai, Inc. | Radiology | QIH |
08/26/2022 | K222277 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
08/25/2022 | K211841 | MRI Planner | Spectronic Medical AB | Radiology | MUJ |
08/25/2022 | K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Cardiovascular | MXD |
08/24/2022 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | Radiology | QKB |
08/22/2022 | K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
08/19/2022 | K222172 | MI View&GO | Siemens Medical Solutio | Radiology | QIH |
08/12/2022 | K213686 | SKOUT Software | Iterative Scopes Inc. | Gastroenterology-Urology | QNP |
08/12/2022 | K220349 | TeraRecon Neuro | TeraRecon, Inc | Radiology | LLZ |
08/11/2022 | K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare Gm | Radiology | JAK |
08/08/2022 | K213645 | ClearPoint Maestro Brain Model | ClearPoint Neuro, Inc. | Radiology | QIH |
08/03/2022 | K221347 | Transpara 1.7.2 | ScreenPoint Medical B.V. | Radiology | QDQ |
08/03/2022 | K221432 | Customize | 3D-Side SA | Radiology | QIH |
07/29/2022 | K213760 | ABMD Software | HeartLung Corporation | Radiology | KGI |
07/29/2022 | K220961 | Deep Learning Image Reconstruction | GE Healthcare Japan Cor | Radiology | JAK |
07/28/2022 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Ima | Radiology | QIH |
07/28/2022 | K221923 | Swoop Portable MR Imaging System | Hyperfine, Inc. | Radiology | LNH |
07/27/2022 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | Cardiovascular | DQK |
07/25/2022 | K220439 | Viz SDH | Viz.ai, Inc. | Radiology | QAS |
07/22/2022 | K220624 | AI4CMR v1.0 | AI4MedImaging Medical | Radiology | LLZ |
07/22/2022 | K220882 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultr | Radiology | IYN |
07/22/2022 | K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultr | Radiology | QIH |
07/20/2022 | K220956 | Libby Echo:Prio | Dyad Medical, Inc | Radiology | QIH |
07/19/2022 | K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | Cardiovascular | DXH |
07/19/2022 | K220815 | BrainInsight | Hyperfine, Inc. | Radiology | QIH |
07/19/2022 | K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, I | Cardiovascular | DQK |
07/18/2022 | K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultr | Radiology | IYN |
07/18/2022 | K221148 | Vivid iq | GE Medical Systems Ultr | Radiology | IYN |
07/15/2022 | K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultr | Radiology | IYN |
07/14/2022 | K221203 | AHI System | Fifth Eye Inc. | Cardiovascular | QNV |
07/13/2022 | K221727 | syngo.CT Extended Functionality | Siemens Medical Solutio | Radiology | JAK |
07/08/2022 | K212783 | ProstatID | ScanMed, LLC | Radiology | QDQ |
07/06/2022 | K210069 | Minuteful - kidney test | Healthy.io Ltd. | Clinical Chemistry | JIR |
06/29/2022 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | Cardiovascular | DQD |
06/29/2022 | K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
06/27/2022 | K220851 | Venue | GE Medical Systems | Radiology | IYN |
06/27/2022 | K220848 | Venue Fit | GE Medical Systems | Radiology | IYN |
06/24/2022 | K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | Siemens Medical Solutio | Radiology | LNH |
06/23/2022 | K220497 | CoLumbo | Smart Soft Healthcare AD | Radiology | QIH |
06/21/2022 | K220800 | Venue Go | GE Medical Systems Ultr | Radiology | IYN |
06/17/2022 | K213037 | IDx-DR v2.3 | Digital Diagnostics Inc. | Ophthalmic | PIB |
06/17/2022 | K221463 | ElucidVivo A.3 | Elucid Bioimaging Inc. | Radiology | LLZ |
06/17/2022 | K220813 | ART-PLAN | TheraPanacea | Radiology | QKB |
06/16/2022 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | Canon Medical Systems | Radiology | JAK |
06/10/2022 | K221393 | Swoop Portable MR Imaging System | Hyperfine, Inc. | Radiology | LNH |
06/08/2022 | K213882 | EarliPoint System | EarliTec Diagnostics, Inc. | Neurology | QPF |
06/08/2022 | K213717 | AIR Recon DL | GE Medical Systems,LLC ( | Radiology | LNH |
06/06/2022 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultr | Radiology | IYN |
06/03/2022 | K213971 | Atrial Fibrillation History Feature | Apple Inc. | Cardiovascular | QDB |
06/03/2022 | K221314 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
06/02/2022 | K220164 | Rayvolve | AZmed SAS | Radiology | QBS |
05/31/2022 | K221248 | Rapid LVO | iSchemaView Inc. | Radiology | QAS |
05/31/2022 | K220766 | eMurmur Heart AI | CSD Labs GmbH | Cardiovascular | DQD |
05/25/2022 | K220416 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
05/17/2022 | K220499 | Rapid PE Triage and Notification (PETN) | iSchemaView Inc. | Radiology | QAS |
05/17/2022 | K221219 | syngo.CT CaScoring | Siemens Medical Solutio | Radiology | JAK |
05/17/2022 | K221240 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
05/16/2022 | K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | Philips Medical Systems | Radiology | LNH |
05/13/2022 | K220589 | MAGNETOM Skyra Fit | Siemens Medical Solutio | Radiology | LNH |
05/13/2022 | K221106 | Quantib Prostate | Quantib BV | Radiology | LLZ |
05/12/2022 | K220105 | Saige-Dx | DeepHealth, Inc. | Radiology | QDQ |
05/11/2022 | K220446 | Versana Balance | GE Medical Systems Ultr | Radiology | IYN |
05/10/2022 | K212519 | Overjet Caries Assist | Overjet, Inc. | Radiology | MYN |
05/06/2022 | K211966 | Segment 3DPrint | Medviso AB | Radiology | LLZ |
05/03/2022 | K212915 | MVision AI Segmentation | MVision AI | Radiology | QKB |
05/03/2022 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs Ltd. | Hematology | JOY |
04/29/2022 | K220899 | Oxehealth Vital Signs | Oxehealth Limited | Cardiovascular | QME |
04/29/2022 | K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | Siemens Medical Solutio | Radiology | LNH |
04/29/2022 | K220590 | aPROMISE X | EXINI Diagnostics AB | Radiology | LLZ |
04/28/2022 | K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.AI Co., Ltd. | Radiology | QKB |
04/27/2022 | K212441 | Philips Incisive CT | Philips Healthcare (Suzh | Radiology | JAK |
04/26/2022 | K213886 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
04/26/2022 | K212662 | AliveCor QT Service | AliveCor, Inc. | Cardiovascular | DQK |
04/22/2022 | K213944 | HealthOST | NanoxAI Ltd. | Radiology | JAK |
04/21/2022 | K213795 | Videa Caries Assist | VideaHealth, Inc | Radiology | MYN |
04/15/2022 | K213706 | AI-Rad Companion Brain MR | Siemens Healthcare Gm | Radiology | QIH |
04/15/2022 | K220141 | RayStation 11B | RaySearch Laboratories | Radiology | MUJ |
04/08/2022 | K212274 | INT Contour | Carina Medical LLC | Radiology | MUJ |
04/08/2022 | K220192 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
04/06/2022 | K203783 | ClariPulmo | ClariPi Inc. | Radiology | LLZ |
04/05/2022 | K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., L | Radiology | IYN |
04/05/2022 | K214081 | MRCAT Head & Neck | Philips Oy | Radiology | MUJ |
04/04/2022 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune. AI Co., Ltd. | Radiology | QIH |
04/01/2022 | K213657 | DEEPVESSEL FFR | KeyaMed NA Inc. | Cardiovascular | PJA |
04/01/2022 | K220151 | MAGNETOM Avanto Fit | Siemens Medical Solutio | Radiology | LNH |
03/22/2022 | K200828 | Athelas Home | Athelas Inc. | Hematology | GKZ |
03/22/2022 | K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems | Radiology | IYN |
03/21/2022 | K213721 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
03/16/2022 | K213779 | Customize | 3D-Side SA | Radiology | QIH |
03/14/2022 | K203744 | Arterys MICA | Arterys Inc. | Radiology | QIH |
03/14/2022 | K214043 | BriefCase | Aidoc Medical, Ltd. | Radiology | QFM |
03/11/2022 | K213725 | CardIQ Suite | GE Medical Systems SCS | Radiology | JAK |
03/10/2022 | K213566 | ClearRead Xray Pneumothorax | Riverain Technologies, I | Radiology | QFM |
03/04/2022 | K210365 | Second Opinion | Pearl Inc. | Radiology | MYN |
03/01/2022 | K212365 | BoneView | Gleamer | Radiology | QBS |
02/25/2022 | K213693 | MAGNETOM Vida with syngo MR XA50A | Siemens Medical Solutio | Radiology | LNH |
02/24/2022 | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-AI | Radiology | QFM |
02/18/2022 | K213999 | Deep Learning Image Reconstruction | GE Medical Systems, LLC. | Radiology | JAK |
02/18/2022 | K213319 | Viz ANEURYSM, Viz ANX | Viz.ai, Inc. | Radiology | QFM |
02/17/2022 | K213689 | Voluson P6, Voluson P8 | GE Healthcare | Radiology | IYN |
02/11/2022 | K213603 | SIGNA Artist Evo | GE Healthcare(Tianjin) C | Radiology | LNH |
02/08/2022 | K213165 | Rapid | iSchema View Inc. | Radiology | LLZ |
02/04/2022 | K212654 | Micro C Medical Imaging System, M01 | OXOS Medical, Inc. | Radiology | IZL |
02/04/2022 | K213938 | Revolution Ascend | GE Healthcare Japan Cor | Radiology | JAK |
02/03/2022 | K213976 | Contour ProtégéAI | MIM Software Inc. | Radiology | QKB |
01/28/2022 | K203260 | syngo.CT Brain Hemorrhage | Siemens Medical Solutio | Radiology | QAS |
01/24/2022 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems | Radiology | IYN |
01/20/2022 | K214019 | syngo.CT Extended Functionality | Siemens Medical Solutio | Radiology | JAK |
01/20/2022 | K213668 | SIGNA Hero | GE Healthcare (GE Medic | Radiology | LNH |
01/19/2022 | K212012 | Follicle Clarity | Cycle Clarity | Radiology | QIH |
01/19/2022 | K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | Radiology | QIH |
01/16/2022 | K211980 | SIGNA Prime | GE Healthcare (Tianjin) C | Radiology | LNH |
01/14/2022 | K213737 | Quantib ND | Quantib B.V. | Radiology | LLZ |
01/14/2022 | K213307 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | Radiology | MQB |
01/14/2022 | K210760 | Precise Image | Philips Medical Systems | Radiology | JAK |
01/13/2022 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | GE Healthcare | Radiology | IYN |
01/12/2022 | K212005 | UNiD Spine Analyzer | MEDICREA International, | Radiology | LLZ |
01/07/2022 | K211443 | AIBOLIT 3D+ | AIbolit Technologies, LLC | Radiology | LLZ |
01/06/2022 | K213544 | TOMTEC-ARENA | TOMTEC Imaging System | Radiology | QIH |
12/29/2021 | K213776 | LiverSmart | Resonance Health Analy | Radiology | PCS |
12/22/2021 | K202404 | BoneMRI | MRIguidance B.V | Radiology | QIH |
12/21/2021 | K212690 | qXR-BT | Qure.ai Technologies | Radiology | QIH |
12/21/2021 | K210670 | BU-CAD | TaiHao Medical Inc. | Radiology | QDQ |
12/20/2021 | K213275 | EchoGo Core (2.0) | Ultromics Limited | Radiology | QIH |
12/16/2021 | K212616 | Koios DS | Koios Medical, Inc. | Radiology | POK |
12/16/2021 | K213628 | VBrain | Vysioneer Inc. | Radiology | QKB |
12/15/2021 | K211803 | HealthPPT | Zebra Medical Vision Ltd. | Radiology | QFM |
12/15/2021 | K213155 | RT-Mind-AI | MedMind Technology Co | Radiology | QKB |
12/09/2021 | K212466 | LVivo Seamless | DiA Imaging Analysis Ltd | Radiology | QIH |
12/06/2021 | K213096 | Al-Rad Companion (Pulmonary) | Siemens Medical Solutio | Radiology | JAK |
12/03/2021 | K212442 | Cydar EV (Series B) and Cydar EV Maps | Cydar Ltd. | Radiology | OWB |
12/03/2021 | K212219 | AHI System | Fifth Eye Inc. | Cardiovascular | QNV |
12/01/2021 | K213305 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
11/26/2021 | K211541 | MammoScreen 2.0 | Therapixel | Radiology | QDQ |
11/19/2021 | K211326 | EndoScreener | Chengdu Wision Medical | Gastroenterology-Urology | QNP |
11/19/2021 | K210831 | OnQ Neuro | CorTechs Labs, Inc | Radiology | QIH |
11/17/2021 | K212336 | Soteria.AI | Omega Medical Imaging, | Radiology | OWB |
11/17/2021 | K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | Radiology | LNH |
11/17/2021 | K211678 | Lunit INSIGHT MMG | Lunit Inc. | Radiology | QDQ |
11/16/2021 | K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/ | Shenzhen Mindray Bio- | Radiology | IYN |
11/15/2021 | K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Co | Radiology | IYN |
11/10/2021 | K211733 | Lunit INSIGHT CXR Triage | Lunit Inc. | Radiology | QFM |
11/03/2021 | K210543 | IM007 | Implicity, Inc. | Cardiovascular | DQK |
10/29/2021 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | GE Medical Systems, LLC | Radiology | QIH |
10/25/2021 | K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | Elekta Solutions AB | Radiology | QKB |
10/22/2021 | K210807 | FlightPlan for Liver | GE Medical Systems SCS | Radiology | LLZ |
10/22/2021 | K212516 | IRNF App | Apple Inc. | Cardiovascular | QDB |
10/20/2021 | K210632 | Contour ProtegeAI | MIM Software Inc. | Radiology | QKB |
10/14/2021 | K212261 | StrokeSENS LVO | Circle Neurovascular Ima | Radiology | QAS |
10/14/2021 | K210999 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
10/12/2021 | K212116 | VBrain-OAR | Vysioneer Inc. | Radiology | QKB |
10/02/2021 | K202927 | EYE-SYNC | SyncThink, Inc. | Neurology | QEA |
09/28/2021 | K211964 | SubtlePET | Subtle Medical, Inc. | Radiology | KPS |
09/24/2021 | K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | Philips Medical Systems | Radiology | IYN |
09/21/2021 | DEN200080 | Paige Prostate | Paige.AI | Pathology | QPN |
09/17/2021 | K212067 | Deep Learning Image Reconstruction | GE Healthcare Japan Cor | Radiology | JAK |
09/17/2021 | K212269 | Intelligent NR | Canon Inc. | Radiology | MQB |
09/15/2021 | K210085 | HealthCCSng | Zebra Medical Vision Ltd. | Radiology | JAK |
09/10/2021 | K203785 | ClariSIGMAM | ClariPi Inc. | Radiology | QIH |
09/10/2021 | K210438 | Versana Premier | GE Medical Systems Ultr | Radiology | IYN |
09/10/2021 | K211828 | Aquilion Exceed LB | Canon Medical Systems | Radiology | JAK |
09/09/2021 | K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Lt | Radiology | IYN |
09/08/2021 | DEN200030 | FEops HEARTguide | FEops NV | Cardiovascular | QQI |
09/08/2021 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | Radiology | IYN |
09/08/2021 | K203555 | AmCAD-UT | AmCad BioMed Corporat | Radiology | QIH |
09/08/2021 | K211867 | RayStation 11.0 | RaySearch Laboratories | Radiology | MUJ |
09/08/2021 | K211945 | V8 Diagnostic Ultrasound System | Samsung Medison CO., L | Radiology | IYN |
09/02/2021 | K211881 | AI Segmentation | Varian Medical Systems, | Radiology | MUJ |
08/31/2021 | K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., | Radiology | MYN |
08/31/2021 | K212383 | EndoNaut | Therenva SAS | Radiology | OWB |
08/27/2021 | K203696 | RBknee | Radiobotics ApS | Radiology | LLZ |
08/20/2021 | K211846 | Discovery MI Gen2 | GE Medical Systems, LLC. | Radiology | KPS |
08/16/2021 | K212230 | TruSPECT Radiological Image Processing Station | Spectrum Dynamics Med | Radiology | LLZ |
08/12/2021 | K211179 | InferRead CT Stroke.AI | Infervision Medical Tech | Radiology | QAS |
08/11/2021 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging | Radiology | JAK |
08/06/2021 | K211764 | Vereos PET/CT | Philips Medical Systems | Radiology | KPS |
08/06/2021 | K212100 | Kosmos | EchoNous, Inc. | Radiology | IYN |
08/02/2021 | K211431 | breastscape v1.0 | Olea Medical | Radiology | QIH |
07/30/2021 | K211379 | syngo.via RT Image Suite | Siemens Medical Solutio | Radiology | MUJ |
07/30/2021 | K211222 | qER-Quant | Qure.ai Technologies | Radiology | QIH |
07/27/2021 | K212074 | ClariCT.AI | ClariPi Inc. | Radiology | LLZ |
07/27/2021 | K210791 | Us2.v1 | eko.ai Pte. Ltd. d/b/a Us | Radiology | QIH |
07/27/2021 | K211279 | Volpara Imaging Software | Volpara Health Technolo | Radiology | LLZ |
07/27/2021 | K211655 | aPROMISE | EXINI Diagnostics AB | Radiology | LLZ |
07/23/2021 | K211951 | GI Genius | Cosmo Artificial Intellige | Gastroenterology-Urology | QNP |
07/20/2021 | K210719 | Change Healthcare Anatomical AI | Change Healthcare Cana | Radiology | QIH |
07/20/2021 | K211906 | Vital Signs | Oxehealth Limited | Cardiovascular | QME |
07/20/2021 | K210666 | Chest-CAD | Imagen Technologies, In | Radiology | MYN |
07/12/2021 | K211506 | PowerLook Density Assessment V4.0 | iCAD, Inc. | Radiology | QIH |
07/08/2021 | K211788 | HALO | Nico.Lab B.V. | Radiology | QAS |
07/01/2021 | K210611 | MAGNETOM Free.Max | Siemens Medical Solutio | Radiology | LNH |
06/29/2021 | K210645 | RayStation 10.1 | RaySearch Laboratories | Radiology | MUJ |
06/17/2021 | K203514 | Precise Position | Philips Healthcare (Suzh | Radiology | JAK |
06/16/2021 | K202718 | Qmenta Care Platform Family | Mint Labs, Inc., d/b/a. Q | Radiology | LLZ |
06/16/2021 | K210034 | EnsoSleep | EnsoData, Inc. | Neurology | OLZ |
06/11/2021 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Cardiovascular | MXD |
06/10/2021 | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutio | Radiology | QIH |
06/10/2021 | K203629 | IDx-DR | Digital Diagnostics Inc. | Ophthalmic | PIB |
06/08/2021 | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | Abbott Medical | Radiology | NQQ |
06/02/2021 | DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | Neurology | QPF |
06/02/2021 | K210404 | Transpara 1.7.0 | ScreenPoint Medical B.V. | Radiology | QDQ |
05/21/2021 | K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, I | Cardiovascular | DQK |
05/19/2021 | K210187 | Overjet Dental Assist | Overjet, Inc. | Radiology | LLZ |
05/19/2021 | K210237 | CINA CHEST | Avicenna.AI | Radiology | QAS |
05/13/2021 | K211118 | SIGNA 7.0T | GE Medical Systems, LLC | Radiology | LNH |
05/13/2021 | K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison CO., L | Radiology | IYN |
04/30/2021 | K210001 | HYPER AiR | Shanghai United Imaging | Radiology | KPS |
04/23/2021 | K203502 | MEDO-Thyroid | MEDO DX Pte. Ltd. | Radiology | QIH |
04/23/2021 | K203314 | Cartesion Prime (PCD-1000A/3) V10.8 | Canon Medical Systems | Radiology | KPS |
04/21/2021 | K210556 | Preview Shoulder | Genesis Software Innova | Radiology | QIH |
04/20/2021 | K203610 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology S | Radiology | QKB |
04/19/2021 | K203469 | AI Segmentation | Varian Medical Systems, | Radiology | MUJ |
04/16/2021 | K203517 | Saige-Q | DeepHealth, Inc. | Radiology | QFM |
04/14/2021 | K202992 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical, Ltd. | Radiology | QFM |
04/09/2021 | DEN200055 | GI Genius | Cosmo Artificial Intellige | Gastroenterology-Urology | QNP |
04/02/2021 | K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | Radiology | MQB |
04/02/2021 | K202928 | DV. Target | Deepvoxel INC | Radiology | QKB |
04/01/2021 | DEN200038 | Gili Pro BioSensor (also known as “Gili BioSensor System”) | ContinUse Biometrics Lt | Cardiovascular | QOK |
03/31/2021 | K210071 | SIS System (Version 5.1.0) | Surgical Information Scie | Radiology | LLZ |
03/31/2021 | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | Siemens Medical Solutio | Radiology | LNH |
03/31/2021 | K203258 | syngo.CT Lung CAD | Siemens Healthcare Gm | Radiology | OEB |
03/26/2021 | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | Cardiovascular | QME |
03/24/2021 | K203225 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System | Canon Medical Systems | Radiology | JAK |
03/23/2021 | K210209 | Viz ICH | Viz.ai, Inc. | Radiology | QAS |
03/19/2021 | K203235 | VBrain | Vysioneer Inc. | Radiology | QKB |
03/12/2021 | K202284 | Oncospace | Oncospace, Inc. | Radiology | MUJ |
03/12/2021 | K203822 | ProFound AI Software V3.0 | iCAD Inc. | Radiology | QDQ |
03/09/2021 | K203256 | Imbio RV/LV Software | Imbio, LLC | Radiology | QIH |
03/05/2021 | K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Optellum Ltd | Radiology | POK |
03/04/2021 | K203323 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
03/02/2021 | K203617 | MaxFOV 2 | GE Medical Systems, LLC. | Radiology | JAK |
03/01/2021 | DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye Inc. | Cardiovascular | QNV |
02/26/2021 | K203182 | SubtleMR | Subtle Medical, Inc. | Radiology | LLZ |
02/25/2021 | K202990 | NinesMeasure | Nines, Inc. | Radiology | LLZ |
02/25/2021 | K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imagi | Radiology | NQQ |
02/19/2021 | K202212 | TruPlan | Circle Cardiovascular Ima | Radiology | LLZ |
02/09/2021 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | Radiology | LLZ |
02/05/2021 | K210053 | LVivo Software Application | DiA Imaging Analysis Ltd | Radiology | QIH |
02/04/2021 | K203582 | QUIBIM Precision Prostate (qp-Prostate) | QUIBIM S.L. | Radiology | LLZ |
01/29/2021 | K201411 | Visage Breast Density | Visage Imaging GmbH | Radiology | QIH |
01/15/2021 | K193271 | uAI EasyTriage-Rib | Shanghai United Imaging | Radiology | QFM |
01/15/2021 | K202767 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems | Radiology | LNH |
01/14/2021 | K202700 | ART-Plan | TheraPanacea | Radiology | QKB |
01/12/2021 | K203280 | Hepatica v1 (Hepatica v1.0.0) | Perspectum Ltd. | Radiology | LNH |
01/12/2021 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems | Radiology | JAK |
01/11/2021 | P200003 | Imagio Breast Imaging System | Seno Medical Instrumen | Radiology | QNK |
01/09/2021 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | CLEW Medical Ltd. | Cardiovascular | QNL |
01/08/2021 | K203329 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
01/07/2021 | K202414 | BrainInsight | Hyperfine Research, Inc | Radiology | LLZ |
12/29/2020 | K203508 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
12/22/2020 | K202229 | AI Metrics | AI Metrics, LLC | Radiology | LLZ |
12/18/2020 | K201555 | EchoGo Pro | Ultromics Ltd | Radiology | POK |
12/10/2020 | K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | Canon Medical Systems | Radiology | JAK |
12/10/2020 | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | GE Medical Systems, LLC | Radiology | JAK |
12/07/2020 | K201039 | HepaFat-AI | Resonance Health Analy | Radiology | LNH |
12/04/2020 | K202487 | HealthJOINT | Zebra Medical Vision Ltd. | Radiology | LLZ |
11/20/2020 | K200873 | HALO | NICo-Lab B.V. | Radiology | QAS |
11/20/2020 | K203169 | Revolution Ascend | GE Healthcare Japan Cor | Radiology | JAK |
11/20/2020 | K193287 | CorInsights MRI | ADM Diagnostics, Inc. | Radiology | LLZ |
11/18/2020 | K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutio | Radiology | QIH |
11/18/2020 | K201019 | Genius AI Detection | Hologic, Inc. | Radiology | QDQ |
11/17/2020 | K193306 | PROView | GE Medical Systems SCS | Radiology | LLZ |
11/12/2020 | K201985 | KardiaAI | AliveCor, Inc. | Cardiovascular | DQK |
11/12/2020 | K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | Radiology | JAK |
11/06/2020 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutio | Radiology | QKB |
11/06/2020 | K200750 | Neuro.Al Algorithm | TeraRecon, Inc. | Radiology | LLZ |
10/30/2020 | K202013 | WRDensity by Whiterabbit.ai | Whiterabbit.ai Inc. | Radiology | QIH |
10/30/2020 | K200323 | AutoContour | Radformation, Inc. | Radiology | QKB |
10/28/2020 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology | POV |
10/16/2020 | K201710 | A View LCS | Coreline Soft Co., Ltd. | Radiology | LLZ |
10/16/2020 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | Hematology | JOY |
10/15/2020 | K201615 | SIGNA 7.0T | GE Medical Systems, LLC | Radiology | LNH |
10/11/2020 | K202501 | Quantib Prostate | Quantib BV | Radiology | LLZ |
10/09/2020 | K193631 | Stethee Pro 1, Stethee Pro Software System | M3DICINE Pty Ltd. | Cardiovascular | DQD |
10/02/2020 | K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | Radiology | LLZ |
10/02/2020 | K202170 | LiverMultiScan | Perspectum LTD | Radiology | LNH |
10/02/2020 | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs LTD. | Hematology | JOY |
09/30/2020 | K192051 | THINQ | CorticoMetrics LLC | Radiology | LLZ |
09/29/2020 | K202546 | LVivo Seamless | DiA Imaging Analysis Ltd | Radiology | QIH |
09/25/2020 | K201103 | Xeleris V Processing and Review Systems | GE Healthcare | Radiology | LLZ |
09/24/2020 | K200569 | RayStation | RaySearch Laboratories | Radiology | MUJ |
09/18/2020 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultr | Radiology | LLZ |
09/18/2020 | K201992 | Caption Guidance | Caption Health | Radiology | QJU |
09/16/2020 | K201369 | AVA (Augmented Vascular Analysis) | See-Mode Technologies | Radiology | LLZ |
09/16/2020 | K201298 | VX1 | Volta Medical | Cardiovascular | DQK |
09/15/2020 | K192665 | Accelerate Pheno System, Accelerate PhenoTest BC Kit | Accelerate Diagnostics, I | Microbiology | PRH |
09/09/2020 | K200851 | Vivid T8, Vivid T9 | GE Medical Systems Ultr | Radiology | IYN |
09/09/2020 | K200708 | Vivid iq | GE Medical Systems Ultr | Radiology | IYN |
09/06/2020 | K201841 | EyeBOX | Oculogica, Inc. | Neurology | QEA |
09/04/2020 | K202238 | SIGNA Artist | GE Healthcare (Tianjin) C | Radiology | LNH |
09/02/2020 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | Cardiovascular | MLO |
08/26/2020 | K201020 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
08/26/2020 | K200714 | AVIEW | Coreline Soft Co., Ltd | Radiology | LLZ |
08/14/2020 | K201632 | TOMTEC-ARENA | TOMTEC Imaging System | Radiology | LLZ |
08/13/2020 | K201232 | Limbus Contour | Limbus AI Inc. | Radiology | LLZ |
08/13/2020 | K201444 | Syngo.via RT Image Suite | Siemens Medical Solutio | Radiology | MUJ |
08/07/2020 | K200990 | VIDAvision | VIDA Diagnostics Inc. | Radiology | JAK |
08/07/2020 | K201310 | Accipiolx | MaxQ Al Ltd. | Radiology | QAS |
08/04/2020 | K193210 | HYPER DLR | Shanghai United Imaging | Radiology | KPS |
08/03/2020 | K200667 | EyeArt | Eyenuk, Inc | Ophthalmic | PIB |
07/30/2020 | K193417 | FractureDetect (FX) | Imagen Technologies, In | Radiology | QBS |
07/30/2020 | K193283 | AI-Rad Companion Prostate MR | Siemens Medical Solutio | Radiology | QIH |
07/23/2020 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultr | Radiology | IYN |
07/22/2020 | K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | Radiology | QIH |
07/16/2020 | K200497 | Vivid S60N, Vivid S70N | GE Medical Systems Ultr | Radiology | IYN |
07/16/2020 | K200905 | HealthMammo | Zebra Medical Vision Ltd. | Radiology | QFM |
07/14/2020 | K193097 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
07/10/2020 | K192969 | Ezra Plexo Software | Ezra AI Inc. | Radiology | QIH |
07/10/2020 | K193294 | AI-Rad Companion Engine | Siemens Medical Solutio | Radiology | LLZ |
07/09/2020 | K200941 | Rapid LVO | iSchemaView Inc. | Radiology | QAS |
07/06/2020 | K193073 | Deep Recon | Shanghai United Imaging | Radiology | JAK |
07/02/2020 | K193252 | Contour ProtegeAI | MIM Software Inc. | Radiology | QKB |
07/02/2020 | K192880 | InferRead Lung CT.AI | Beijing Infervision Techn | Radiology | OEB |
06/26/2020 | K200760 | Rapid ASPECTS | iSchemaView Inc. | Radiology | POK |
06/24/2020 | K200855 | CINA | AVICENNA.AI | Radiology | QAS |
06/23/2020 | K200232 | LVivo Software Application | DiA Imaging Analysis Ltd | Radiology | QIH |
06/19/2020 | K193298 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
06/17/2020 | K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutio | Radiology | LLZ |
06/17/2020 | K200921 | qER | Qure.ai Technologies | Radiology | QAS |
06/11/2020 | K200356 | MEDO ARIA | Medo.ai | Radiology | QIH |
06/11/2020 | K200980 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | Radiology | IYO |
06/03/2020 | K200974 | QLAB Advanced Quantification Software | Philips Healthcare | Radiology | QIH |
06/01/2020 | K192601 | uWS-MR | Shanghai United Imaging | Radiology | QIH |
05/14/2020 | K201034 | Syngo.CT CaScoring | Siemens Medical Solutio | Radiology | JAK |
05/12/2020 | K192901 | HealthVCF | Zebra Medical Vision Ltd. | Radiology | QFM |
05/05/2020 | K193220 | AVIEW LCS | Coreline Soft Co., Ltd | Radiology | LLZ |
05/05/2020 | K193176 | uMR 780 | Shanghai United Imaging | Radiology | LNH |
05/01/2020 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq D | Philips Ultrasound, Inc. | Radiology | IYN |
04/21/2020 | K193351 | NinesAI | Nines, Inc. | Radiology | QAS |
04/16/2020 | K200755 | Caption Guidance | Caption Health | Radiology | QJU |
04/13/2020 | K192167 | CuraRad-ICH | CuraCloud Corp. | Radiology | QAS |
04/10/2020 | K193282 | SIGNA Premier | GE Healthcare (GE Medic | Radiology | LNH |
04/08/2020 | K193300 | AIMI-Triage CXR PTX | RADLogics, Inc. | Radiology | QFM |
03/31/2020 | K193087 | Rapid ICH | iSchemaView Incorporat | Radiology | QAS |
03/26/2020 | K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies | Cardiovascular | DSI |
03/26/2020 | K193518 | KOSMOS | EchoNous, Inc. | Radiology | IYN |
03/25/2020 | K192437 | Arterys MICA | Arterys Inc. | Radiology | QIH |
03/25/2020 | K192854 | MammoScreen | Therapixel | Radiology | QDQ |
03/20/2020 | K200036 | AI-ECG Tracker | Shenzhen Carewell Elect | Cardiovascular | DPS |
03/20/2020 | K193281 | Hepatic VCAR | GE Medical Systems SCS | Radiology | JAK |
03/18/2020 | K193658 | Viz ICH | Viz.ai, Inc. | Radiology | QAS |
03/16/2020 | K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutio | Radiology | JAK |
03/12/2020 | K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation In | Radiology | IYN |
03/09/2020 | K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems | Radiology | LNH |
03/09/2020 | K193216 | syngo.CT Lung CAD | Siemens Medical Solutio | Radiology | OEB |
03/05/2020 | K193229 | Transpara | ScreenPoint Medical B.V. | Radiology | QDQ |
03/04/2020 | K191550 | Broncholab | Fluidda Inc. | Radiology | JAK |
02/28/2020 | K191556 | Red Dot | Behold.AI Technologies | Radiology | QFM |
02/28/2020 | K192962 | icobrain-ctp | Icometrix NV | Radiology | LLZ |
02/28/2020 | K191928 | AccuContour | Xiamen Manteia Technol | Radiology | QKB |
02/21/2020 | K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems | Radiology | JAK |
02/19/2020 | K192973 | densitas densityai | Densitas, Inc. | Radiology | LLZ |
02/14/2020 | K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | Siemens Medical Solutio | Radiology | KPS |
02/13/2020 | K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Canon Medical Systems | Radiology | JAK |
02/12/2020 | K193178 | Biograph Horizon | Siemens Medical Solutio | Radiology | KPS |
02/10/2020 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, | Radiology | IYE |
02/07/2020 | DEN190040 | Caption Guidance | Bay Labs, Inc. | Radiology | QJU |
01/24/2020 | K193109 | MRCAT brain | Philips Medical Systems | Radiology | MUJ |
01/17/2020 | K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences LLC | Cardiovascular | DXH |
01/16/2020 | K192956 | Auto Positioning | GE Hangwei Medical Syst | Radiology | JAK |
01/15/2020 | K191125 | ADAS 3D | Galgo Medical S.L | Radiology | LLZ |
01/15/2020 | K192004 | Eko Analysis Software | Eko Devices Inc | Cardiovascular | MWI |
01/02/2020 | K183089 | Air Next | NuvoAir AB | Anesthesiology | BZG |
12/20/2019 | K192383 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
12/20/2019 | K191647 | QLAB Advanced Quantification Software | Philips Healthcare | Radiology | QIH |
12/17/2019 | K192763 | syngo.CT CaScoring | Siemens Medical Solutio | Radiology | JAK |
12/13/2019 | K193170 | Deep Learning Image Reconstruction | GE Healthcare Japan Cor | Radiology | JAK |
12/13/2019 | K192531 | QyScore Software | Qynapse | Radiology | LLZ |
12/13/2019 | K192130 | Icobrain | Icometrix NV | Radiology | LLZ |
12/11/2019 | K192571 | NemoScan | Software Nemotec S.L. | Radiology | LLZ |
12/10/2019 | K192287 | Transpara | Screenpoint Medical B.V. | Radiology | QDQ |
12/09/2019 | K192442 | FFRangio | CathWorks Ltd | Cardiovascular | QEK |
12/07/2019 | K192279 | PhantomMSK Trauma | OrthoGrid Systems Inc. | Radiology | LLZ |
11/27/2019 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical Inc. | Neurology | HAW |
11/26/2019 | K192320 | HealthCXR | Zebra Medical Vision, Lt | Radiology | QFM |
11/25/2019 | K190529 | SOZO | ImpediMed Limited | Cardiovascular | QJB |
11/19/2019 | K191278 | RSI-MRI+ | MultiModal Imaging Serv | Radiology | LLZ |
11/13/2019 | K191171 | EchoGo Core | Ultromics Ltd | Radiology | QIH |
11/07/2019 | K191026 | MEDIP PRO | MEDICALIP Co., Ltd | Radiology | LLZ |
11/05/2019 | K192109 | KOALA | IB Lab GmbH | Radiology | LLZ |
11/05/2019 | K190868 | Cleerly Labs | Cleerly Inc | Radiology | LLZ |
11/04/2019 | K190013 | WellDoc BlueStar | WellDoc, Inc. | General Hospital | MRZ |
11/01/2019 | K190334 | MIMOSA Imager | MIMOSA Diagnostics Inc | Cardiovascular | MUD |
11/01/2019 | K190898 | Sight OLO | Sight Diagnostics Ltd. | Hematology | GKZ |
10/18/2019 | K183274 | RTHawk, HeartVista Cardiac Package | HeartVista, Inc. | Radiology | LNH |
10/17/2019 | K192455 | Merge PACS | Merge Healthcare Incorp | Radiology | LLZ |
10/16/2019 | K191493 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics, | Radiology | LLZ |
10/04/2019 | K191994 | ProFound AI Software V2.1 | iCAD Inc. | Radiology | QDQ |
10/04/2019 | K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) | Omega Medical Imaging, | Radiology | JAA |
09/18/2019 | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutio | Radiology | MUJ |
09/16/2019 | K191688 | SubtleMR | Subtle Medical, Inc. | Radiology | LLZ |
09/13/2019 | K192304 | SIS Software Version 3.6.0 | Surgical Information Scie | Radiology | LLZ |
09/11/2019 | K183370 | PeraMobile and PeraWatch | PeraHealth, Inc. | Cardiovascular | MWI |
09/11/2019 | K190815 | BrainScope TBI | BrainScope Company, In | Neurology | PIW |
09/10/2019 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutio | Radiology | JAK |
09/04/2019 | K191179 | Myo Plus | Otto Bock Healthcare Pro | Neurology | GXY |
08/29/2019 | K183489 | D2P | 3D Systems, Inc. | Radiology | LLZ |
08/29/2019 | K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Co | Radiology | IYN |
08/23/2019 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, I | Cardiovascular | DQK |
08/15/2019 | K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
08/15/2019 | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pt | Cardiovascular | PLB |
08/12/2019 | K183182 | Critical Care Suite | GE Medical Systems, LLC. | Radiology | QFM |
08/05/2019 | K191262 | aBSI | EXINI Diagnostics AB | Radiology | LLZ |
07/31/2019 | K191183 | EyeBOX | Oculogica, Inc. | Neurology | QEA |
07/26/2019 | K182384 | ACR LAB Urine Analysis Test System | Healthy.io Ltd | Clinical Chemistry | JFY |
07/26/2019 | K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutio | Radiology | JAK |
07/19/2019 | K182798 | KIDScore D3 | Vitrolife A/S | Obstetrics and Gynecology | PBH |
07/18/2019 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes Ltd | Clinical Chemistry | QCC |
07/12/2019 | K191585 | iNtuition-Structural Heart Module | TeraRecon Inc. | Radiology | LLZ |
07/10/2019 | K182875 | DeepCT | Deep01 Limited | Radiology | QAS |
07/10/2019 | K183322 | physIQ Heart Rhythm and Respiratory Module | physIQ, Inc | Cardiovascular | DPS |
07/08/2019 | K191384 | RayCare 2.3 | RaySearch Laboratories | Radiology | MUJ |
07/05/2019 | K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Canon Medical Systems | Radiology | JAK |
07/03/2019 | K190442 | Koios DS for Breast | Koios Medical, Inc. | Radiology | POK |
06/27/2019 | K190017 | LiverMultiScan (LMSv3) | Perspectum Diagnostics | Radiology | LNH |
06/25/2019 | K191194 | CLARUS | Carl Zeiss Meditec, Inc | Ophthalmic | QER |
06/19/2019 | K190387 | RayStation | RaySearch Laboratories | Radiology | MUJ |
06/13/2019 | K183460 | ClariCT.AI | ClariPI Inc. | Radiology | LLZ |
06/13/2019 | K190424 | HealthICH | Zebra Medical Vision Ltd. | Radiology | QAS |
06/12/2019 | K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Canon Medical Systems | Radiology | JAK |
05/31/2019 | K190896 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
05/24/2019 | K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | Neurology | GXY |
05/21/2019 | K183646 | Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Mo | Edwards Lifeciences, LLC | Cardiovascular | QAQ |
05/15/2019 | K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems | Microbiology | PPU |
05/13/2019 | K190764 | SurgicalAR | MEDIVIS, Inc. | Radiology | LLZ |
05/06/2019 | K190362 | HealthPNX | Zebra Medical Vision Ltd | Radiology | QFM |
04/22/2019 | K182513 | FluChip-8G Influenza A+B Assay | InDevR, Inc. | Microbiology | OZE |
04/18/2019 | K183593 | Lung Vision System | Body Vision Medical Ltd. | Radiology | LLZ |
04/17/2019 | K181988 | eMurmur ID | CSD Labs GmbH | Cardiovascular | DQD |
04/15/2019 | K190072 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
04/12/2019 | K183202 | Deep Learning Image Reconstruction | GE Medical Systems, LLC. | Radiology | JAK |
04/08/2019 | K183204 | Bone VCAR (BVCAR) | GE Medical Systems SCS | Radiology | JAK |
03/29/2019 | K181352 | Loop System | Spry Health, Inc. | Cardiovascular | DQA |
03/19/2019 | K183019 | SIS Software version 3.3.0 | Surgical Information Scie | Radiology | LLZ |
03/11/2019 | K181823 | KardiaAI | AliveCor, Inc. | Cardiovascular | DQK |
03/08/2019 | K183285 | cmTriage | CureMetrix, Inc | Radiology | QFM |
03/07/2019 | K182344 | RhythmAnalytics | Biofourmis Singapore Pt | Cardiovascular | DQK |
02/16/2019 | K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | Cardiovascular | DXH |
02/04/2019 | K181916 | d-Nav System | Hygieia, Inc | Anesthesiology | NDC |
02/01/2019 | K183272 | AI Rad Companion (Engine) | Siemens Medical Solutio | Radiology | LLZ |
01/18/2019 | K183231 | SIGNA Premier | GE Medical Systems, LLC | Radiology | LNH |
01/17/2019 | K182456 | Study Watch | Verily Life Sciences LLC | Cardiovascular | DXH |
01/09/2019 | K183133 | MRCP+ v1.0 | Perspectum Diagnostics | Radiology | LLZ |
12/28/2018 | DEN170091 | EyeBOX | Oculogica, Inc. | Neurology | QEA |
12/28/2018 | K180867 | AmCAD-UO | AmCad BioMed Corporat | Radiology | LLZ |
12/27/2018 | K182564 | Quantib ND | Quantib BV | Radiology | LLZ |
12/27/2018 | K182130 | iSchemaView RAPID | iSchemaView, Inc. | Radiology | LLZ |
12/21/2018 | K183012 | vascuCAP | Elucid Bioimaging Inc. | Radiology | LLZ |
12/20/2018 | K181861 | Embrace | Empatica Srl | Neurology | POS |
12/19/2018 | K182149 | FFRangio System | CathWorks Ltd | Cardiovascular | QEK |
12/14/2018 | K182419 | Centricity Universal Viewer | GE Healthcare | Radiology | LLZ |
12/14/2018 | K182790 | Cardio-TriTest v6.5 | Cardio-Phoenix Inc. | Cardiovascular | DPS |
12/06/2018 | K182373 | PowerLook Tomo Detection V2 Software | iCAD Inc. | Radiology | QDQ |
12/06/2018 | K173749 | AMRA Profiler | AMRA Medical AB | Radiology | LNH |
12/06/2018 | K182035 | FFRct | HeartFlow, Inc | Cardiovascular | PJA |
11/30/2018 | K182336 | SubtlePET | Subtle Medical, Inc. | Radiology | KPS |
11/30/2018 | K182218 | FerriSmart Analysis System | Resonance Health Analy | Radiology | PCS |
11/29/2018 | K182181 | Persyst 14 EEG Review and Analysis Software | Persyst Development Co | Neurology | OMB |
11/21/2018 | K181704 | Transpara | ScreenPoint Medical BV | Radiology | QDQ |
11/20/2018 | K181247 | Vitrea CT Brain Perfusion | Vital Images, Inc. | Radiology | LLZ |
11/19/2018 | K180432 | AI-ECG Platform | Shenzhen Carewell Elect | Cardiovascular | DQK |
11/16/2018 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology | POV |
11/06/2018 | K181939 | icobrain | icometrix NV | Radiology | LLZ |
11/05/2018 | K181288 | Athelas One | Athelas Inc. | Hematology | GKZ |
11/02/2018 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | NinePoint Medical, Inc. | Radiology | NQQ |
10/26/2018 | K182177 | Accipiolx | MaxQ-Al Ltd. | Radiology | QAS |
10/25/2018 | K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultr | Radiology | IYN |
10/17/2018 | K182034 | Arterys MICA | Arterys Inc. | Radiology | LLZ |
10/09/2018 | K181892 | Ziostation2 | Ziosoft, Inc. | Radiology | LLZ |
10/05/2018 | K182112 | Sense System with IBT Electrodes | Infinite Biomedical Tech | Neurology | GXY |
09/28/2018 | K173872 | FibriCheck | Qompium nv | Cardiovascular | DXH |
09/28/2018 | K181771 | RightEye Vision System | RightEye, LLC | Neurology | GWN |
09/21/2018 | K182310 | Volpara Imaging Software | Volpara Health Technolo | Radiology | LLZ |
08/29/2018 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, I | Cardiovascular | DQK |
08/23/2018 | DEN170090 | MATRx plus | Zephyr Sleep Technologi | Dental | QCJ |
08/01/2018 | K180647 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
07/23/2018 | K173444 | Quantitative Total Extensible Imaging (QTxI) | AIQ Solutions, Inc. | Radiology | LLZ |
07/18/2018 | K173327 | DIP/U.S. Urine Analysis Test System | Healthy.io Ltd | Clinical Chemistry | JIL |
07/10/2018 | K181572 | Workflow Box | Mirada Medical Ltd. | Radiology | QKB |
07/10/2018 | K181574 | Uscan | EchoNous, Inc. | Radiology | IYO |
06/29/2018 | K180038 | NuVasive Pulse System | NuVasive, Incorporated | Neurology | OLO |
06/26/2018 | K173574 | DenSeeMammo | Statlife | Radiology | LLZ |
06/14/2018 | K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | Radiology | LLZ |
06/13/2018 | K172983 | HealthCCS | Zebra Medical Vision Ltd. | Radiology | JAK |
06/12/2018 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | Clinical Chemistry | QCC |
06/05/2018 | K173821 | LungQ Software | Thirona Corporation | Radiology | JAK |
05/25/2018 | K180163 | TransEnterix Senhance Surgical System | TransEnterix, Inc. | Gastroenterology-Urology | NAY |
05/24/2018 | DEN180005 | OsteoDetect | Imagen Technologies, In | Radiology | QBS |
05/14/2018 | K173810 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics, | Radiology | IYN |
05/14/2018 | K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Co | Radiology | IYN |
05/02/2018 | K180599 | Venue | GE Medical Systems Ultr | Radiology | IYN |
05/01/2018 | K172959 | PeraServer and PeraTrend | PeraHealth, Inc. | Cardiovascular | MWI |
04/20/2018 | K180161 | Viz CTP | Viz.ai, Inc. | Radiology | LLZ |
04/16/2018 | K180126 | SOZO | ImpediMed Limited | Cardiovascular | OBH |
04/11/2018 | DEN180001 | IDx-DR | IDx, LLC | Ophthalmic | PIB |
04/05/2018 | K180589 | DR 800 with MUSICA Dynamic | Agfa HealthCare N.V. | Radiology | JAA |
03/16/2018 | DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences LLC | Cardiovascular | QAQ |
03/15/2018 | K173839 | Tissue of Origin Test Kit-FFPE | Cancer Genetics, Inc. | Clinical Tcxicology | OIW |
03/09/2018 | K173939 | Quantib Brain | Quantib BV | Radiology | LLZ |
03/08/2018 | K173605 | iQMR | Medic Vision - Imaging S | Radiology | LLZ |
02/23/2018 | K170540 | DM-Density | Densitas, Inc. | Radiology | LLZ |
02/13/2018 | DEN170073 | ContaCT | Viz.Al, Inc. | Radiology | QAS |
02/08/2018 | K180091 | UNiD Spine Analyzer | Medicrea International | Radiology | LLZ |
01/25/2018 | K173542 | Arterys Oncology DL | Arterys Inc. | Radiology | LLZ |
01/12/2018 | K173588 | Illumeo System | Philips Medical Systems | Radiology | LLZ |
01/11/2018 | K171122 | CEREC Ortho Software | Dentsply Sirona | Dental | PNN |
01/08/2018 | K171328 | cNeuro cMRI | Combinostics Oy | Radiology | LLZ |
01/04/2018 | K171056 | WAVE Clinical Platform | Excel Medical Electronics | Cardiovascular | MWI |
12/27/2017 | K173420 | Radiomics App v1.0 | Microsoft Corp. | Radiology | LLZ |
12/22/2017 | K172507 | SOZO | ImpediMed Limited | Cardiovascular | DSB |
11/07/2017 | K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs Ltd. | Cardiovascular | DRG |
10/27/2017 | K172803 | Infinitt PACS 7.0 | Infinitt Healthcare Co.,Lt | Radiology | LLZ |
10/20/2017 | K163623 | Quantra | HOLOGIC, INC. | Radiology | LLZ |
09/27/2017 | K171936 | Peerbridge Cor(TM) System | Peerbridge Health INc. | Cardiovascular | DSH |
09/15/2017 | K172356 | BladderScan Prime PLUS System | Verathon Incorporated | Radiology | IYO |
09/14/2017 | K172385 | Clarius Ultrasound System | Clarius Mobile Health Co | Radiology | IYN |
09/07/2017 | K170981 | NeuroQuant | CorTechs Labs, Inc | Radiology | LLZ |
08/17/2017 | K163339 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | SPECTRALMD, INC. | Cardiovascular | DPT |
08/11/2017 | K172122 | SOZO | ImpediMed Limited | Cardiovascular | OBH |
08/01/2017 | K171315 | Advanced RBC Application | Cella Vision AB | Hematology | JOY |
07/19/2017 | DEN170022 | QuantX | Quantitative Insights, Inc | Radiology | POK |
06/28/2017 | P150046 | NEVISENSE | SCIBASE AB | General & Plastic Surgery | ONV |
06/26/2017 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | Cardiovascular | DPS |
06/09/2017 | K170747 | syngo Application Software | Siemens Medical Solutio | Radiology | LLZ |
06/07/2017 | K170250 | SmartTarget | SmartTarget, Ltd. | Radiology | LLZ |
05/24/2017 | K170172 | UNiD Spine Analyzer | MEDICREA INTERNATION | Radiology | LLZ |
05/11/2017 | K163622 | Lung Vision | BODY VISION MEDICAL L | Radiology | LLZ |
05/05/2017 | K163665 | MATRx plus | Zephyr Sleep Technologi | Anesthesiology | MNR |
04/26/2017 | K170069 | AmCAD-UV | AmCad BioMed Corporat | Radiology | LLZ |
04/06/2017 | DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23andMe, Inc. | Immunology | PTA |
03/24/2017 | P160009 | PowerLook® Tomo Detection Software | iCAD Inc | Radiology | MYN |
02/23/2017 | K162855 | Reveal LINQ | Medtronic, Inc. | Cardiovascular | MXD |
02/14/2017 | K162830 | SIS Software | Surgical Information Scie | Radiology | LLZ |
01/06/2017 | K163013 | Quantib Brain 1.2 | Quantib BV | Radiology | LLZ |
01/05/2017 | K163253 | Arterys Cardio DL | ARTERYS INC. | Radiology | LLZ |
12/28/2016 | K161959 | ClearView cCAD | ClearView Diagnostics In | Radiology | LLZ |
12/07/2016 | K161322 | CT CoPilot | ZEPMED, LLC. | Radiology | LLZ |
11/30/2016 | K161834 | One Drop Blood Glucose Monitoring System | AgaMatrix, Inc. | Clinical Chemistry | NBW |
11/30/2016 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Co | Radiology | IYN |
11/09/2016 | P150043 | QVCAD System | QView Medical, Inc. | Radiology | MYN |
10/19/2016 | K160401 | Tyto Stethoscope | Tyto Care Ltd. | Cardiovascular | DQD |
09/22/2016 | K161068 | Ahead 300 | BRAINSCOPE COMPANY I | Neurology | PIW |
09/19/2016 | K161625 | PixelShine | ALGOMEDICA | Radiology | LLZ |
09/09/2016 | K161201 | ClearRead CT | RIVERAIN TECHNOLOGIE | Radiology | OEB |
08/24/2016 | K161772 | FFRct | HEARTFLOW, INC. | Cardiovascular | PJA |
08/09/2016 | K161148 | icobrain | Icometrix | Radiology | LLZ |
08/05/2016 | K160338 | Triton System | GAUSS SURGICAL INC. | General Hospital | PBZ |
07/28/2016 | K161382 | LVivo Software Application | DIACARDIO, LTD. | Radiology | LLZ |
07/15/2016 | K160016 | Steth IO | STRATOSCIENTIFIC, INC. | Cardiovascular | DQD |
07/07/2016 | K160088 | Cydar EV | Cydar Ltd. | Radiology | OWB |
06/17/2016 | K153351 | Quantib Brain 1 | QUANTIB BV | Radiology | LLZ |
01/13/2016 | K152733 | FFRct | HEARTFLOW, INC. | Cardiovascular | PJA |
01/07/2016 | K153427 | Volpara Imaging Software | Matakina Technology LT | Radiology | LLZ |
12/21/2015 | K150817 | Dario Blood Glucose Monitoring System | LabStyle Innovations Ltd. | Clinical Chemistry | NBW |
11/05/2015 | K150102 | SnoreSounds | APPIAN MEDICAL, INC. | Anesthesiology | MNR |
06/11/2015 | K142512 | Personalized Physiology Analytics Engine software | VGBio, Inc (DBA PhysIQ) | Cardiovascular | PLB |
05/15/2015 | K143643 | Brainscope Ahead 200 | BRAINSCOPE COMPANY, | Neurology | PIW |
04/24/2015 | K142918 | EndoTool SubQ | MONARCH MEDICAL TEC | Anesthesiology | NDC |
02/27/2015 | K141922 | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | INTELLIGENT RETINAL IM | Radiology | NFJ |
11/17/2014 | DEN140025 | BrainScope Ahead 100 | BRAINSCOPE COMPANY, | Neurology | PIW |
10/10/2014 | K142037 | QUANTRA | HOLOGIC, INC. | Radiology | LLZ |
09/17/2014 | K141069 | Lung Density Analysis | IMBIO LLC | Radiology | JAK |
08/22/2014 | K141480 | CVI42 | CIRCLE CARDIOVASCULA | Radiology | LLZ |
04/22/2014 | K133649 | HEPATIC VCAR | GE MEDICAL SYSTEMS SC | Radiology | JAK |
01/24/2014 | K133259 | YSIO MAX | SIEMENS MEDICAL SOLUT | Radiology | KPR |
11/21/2013 | K130831 | MALDI BIOTYPER CA (MBT-CA) SYSTEM | BRUKER DALTONICS, INC | Microbiology | PEX |
09/04/2013 | K131044 | SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION | DIACOUSTIC MEDICAL DE | Cardiovascular | DQD |
08/21/2013 | DEN130013 | VITEK MS | BIOMERIEUX, INC. | Microbiology | PEX |
03/22/2013 | K120771 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | BECKMAN COULTER, INC. | Hematology | GKZ |
12/27/2012 | P110014 | DUNE MEDICAL DEVICES MARGINPROBE SYSTEM | Dilon Medical Technolog | General & Plastic Surgery | OEE |
12/27/2012 | K123526 | CLEARREAD +CONFIRM | RIVERAIN TECHNOLOGIE | Radiology | LLZ |
07/27/2012 | K121617 | SENSICARDIAC | DIACOUSTIC MEDICAL (P | Cardiovascular | DQD |
05/17/2012 | K120489 | TISSUE OF ORIGIN TEST KIT FFPE | PATHWORK DIAGNOSTIC | Clinical Tcxicology | OIW |
04/13/2012 | K120161 | ALPHAPOINT IMAGING SOFTWARE | RADLOGICS, INC. | Radiology | LLZ |
12/28/2011 | K111776 | DELTAVIEW MODEL 2.1 | RIVERAIN MEDICAL GRO | Radiology | LLZ |
11/01/2011 | P090012 | MELAFIND | STRATA SKIN SCIENCES, I | General & Plastic Surgery | OYD |
09/16/2011 | K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CELLAVISION AB | Hematology | JOY |
06/08/2010 | K092967 | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE | PATHWORK DIAGNOSTIC | Clinical Tcxicology | OIW |
05/12/2010 | K092116 | EASYCELL CELL LOCATOR | MEDICA CORP. | Hematology | JOY |
12/05/2008 | K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CELLAVISION AB | Hematology | JOY |
09/12/2008 | K082483 | QUANTRA | HOLOGIC, INC. | Radiology | LLZ |
07/30/2008 | K080896 | PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST | PATHWORK DIAGNOSTIC | Clinical Tcxicology | OIW |
07/17/2008 | K081140 | VISENSIA | OBS MEDICAL | Cardiovascular | MHX |
05/15/2008 | K080762 | IB NEURO, VERSION 1.0 | IMAGING BIOMETRICS, LL | Radiology | LNH |
03/16/2006 | P040028 | LUMA CERVICAL IMAGING SYSTEM | SPECTRA SCIENCE | Obstetrics/Gynecology | MWM |
10/27/2005 | K043341 | BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION S | BIO-RAD LABORATORIES, | Clinical Tcxicology | NVI |
02/10/2004 | K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | CELLAVISION AB | Hematology | JOY |
01/31/2002 | P010034 | SECOND LOOK ™ | ICAD, INC. | Radiology | MYN |
07/12/2001 | P000041 | RAPIDSCREEN RS-2000 | RIVERAIN MEDICAL GRO | Radiology | MYN |
03/15/2001 | K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | CELLAVISION AB | Hematology | JOY |
09/02/1998 | P980025 | LOGICON CARIES DETECTOR | CARESTREAM DENTAL LL | Radiology | MYN |
06/26/1998 | P970058 | M1000 IMAGECHECKER | Hologic, Inc. | Radiology | MYN |
03/11/1997 | K955841 | SLEEP SYSTEM FOR CLINICS & RESEARCH | COMPUMEDICS PTD LTD. | Anesthesiology | MNR |
11/08/1995 | P940029 | PAPNET Testing System | Neuromedical Systems, I | Pathology | MNM |
09/29/1995 | P950009 | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM | BD DIAGNOSTICS | Pathology | NMN |