Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
August 7, 2024 update: The U.S. Food and Administration updated the list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. With this update, the FDA has authorized 950 AI/ML-enabled medical devices.
The FDA is providing this list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.
Contents of this list: This list contains publicly available information on AI/ML-enabled devices. The FDA compiled this list from the FDA’s publicly-facing information, including public-facing summaries and AI/ML specific product codes, as well as information in the publicly available resources cited below (*) and in other publicly available materials published by the specific manufacturers.
This list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. Rather, it is a list of medical devices that incorporate AI/ML across medical disciplines, primarily based on information provided in the summary descriptions of their marketing authorization document.
Updates to this list: The FDA updates this list on a periodic basis based on publicly available information. Send questions or feedback on this list to digitalhealth@fda.hhs.gov.
AI/ML-Enabled Medical Devices
This list contains publicly available information on AI/ML-enabled devices.
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 |
|---|---|---|---|---|---|
| 06/25/2024 | K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | Cardiovascular | MWI |
| 06/25/2024 | K240582 | VEA Align; spineEOS | EOS imaging | Radiology | QIH |
| 06/21/2024 | K240465 | O-arm O2 Imaging System | Medtronic Navigation, Inc | Radiology | OWB |
| 06/21/2024 | K233196 | Medihub Prostate | JLK Inc. | Radiology | QIH |
| 06/21/2024 | K233253 | eCARTv5 Clinical Deterioration Suite ("eCART") | AgileMD, Inc. | Cardiovascular | MWI |
| 06/21/2024 | K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 06/21/2024 | K233549 | Tempus ECG-AF | Tempus AI, Inc. | Cardiovascular | SBQ |
| 06/20/2024 | K240642 | SMART Bun-Yo-Matic CT | Disior Ltd | Radiology | QIH |
| 06/14/2024 | K232879 | Roche Digital Pathology Dx (VENTANA DP 200) | Ventana Medical Systems, Inc. | Pathology | PSY |
| 06/14/2024 | K233955 | Clarius OB AI | Clarius Mobile Health Corp. | Radiology | IYN |
| 06/14/2024 | K241083 | SIS System | Surgical Information Sciences, Inc. | Radiology | QIH |
| 06/13/2024 | K233662 | Radiography 7300 C | Philips Medical Systems DMC GmbH | Radiology | KPR |
| 06/13/2024 | K233925 | Relu Creator | Relu BV | Radiology | QIH |
| 06/12/2024 | K240516 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 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 Imaging | Radiology | QIH |
| 06/07/2024 | K231010 | Corvair | AliveCor, Inc. | Cardiovascular | MHX |
| 06/07/2024 | K232035 | Impala | AliveCor, Inc. | Cardiovascular | DPS |
| 06/05/2024 | K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation Inc. | General Hospital | FLL |
| 05/31/2024 | K240612 | CINA-VCF | Avicenna.AI | Radiology | QFM |
| 05/24/2024 | K234154 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | OUO |
| 05/24/2024 | K240769 | LVivo IQS | DiA Imaging Analysis Ltd. | Radiology | QIH |
| 05/23/2024 | K233108 | VinDr-Mammo | VinBigData Joint Stock Company | Radiology | QFM |
| 05/23/2024 | K240294 | Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH | Radiology | LLZ |
| 05/21/2024 | K233543 | YSIO X.pree | Siemens Medical Solutions | Radiology | KPR |
| 05/17/2024 | K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | 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 |
| 05/10/2024 | K232410 | SmartChest | Milvue | Radiology | QFM |
| 05/07/2024 | K232928 | DeepContour (V1.0) | Wisdom Technologies., Inc. | Radiology | QKB |
| 05/07/2024 | K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | Cardiovascular | MWJ |
| 05/03/2024 | K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK |
| 05/03/2024 | K233687 | ECHELON Synergy V10.0 | Fujifilm Healthcare Americas Corporation | Radiology | LNH |
| 05/03/2024 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray Inc. | Hematology | LKM |
| 04/30/2024 | K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems Inc. | Radiology | IYE |
| 04/29/2024 | K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. | Neurology | OLO |
| 04/26/2024 | K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Radiology | MUJ |
| 04/26/2024 | K240406 | Sonio Detect | Sonio | Radiology | IYN |
| 04/26/2024 | K233673 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd | Radiology | LNH |
| 04/25/2024 | K232331 | InVision Precision LVEF (LVEF) | InVision Medical Technology Corporation | 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 | K233582 | Rapid | iSchema View Inc. | Radiology | LLZ |
| 04/22/2024 | K234068 | ART-Plan (v.2.2.0) | Therapanacea SAS | Radiology | MUJ |
| 04/19/2024 | K240781 | SKOUT® system | Iterative Scopes, Inc. | Gastroenterology-Urology | QNP |
| 04/17/2024 | K233186 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | QIH |
| 04/16/2024 | K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | Pathology | PSY |
| 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 Corporation | Radiology | LNH |
| 04/11/2024 | K233698 | True Enhance DL | GE Healthcare Japan Corporation | Radiology | JAK |
| 04/10/2024 | K240744 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 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, Department of the Army (TSG-DA) | 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 Innovations | Radiology | QIH |
| 04/03/2024 | K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | Radiology | QKB |
| 04/03/2024 | K233618 | Oxevision Sleep Device | Oxehealth Limited | Neurology | LEL |
| 04/02/2024 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | Radiology | JAK |
| 04/01/2024 | K233676 | Us2.v2 | Eko.ai Pte. Ltd d/b/a Us2.ai | Radiology | QIH |
| 03/29/2024 | K233211 | AVIEW CAC | Coreline Soft Co., Ltd. | Radiology | QIH |
| 03/28/2024 | K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 03/28/2024 | K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | Cardiovascular | QXO |
| 03/26/2024 | K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 03/22/2024 | K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 03/22/2024 | K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | Radiology | QAS |
| 03/22/2024 | K240540 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH |
| 03/21/2024 | K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | Radiology | JAK |
| 03/20/2024 | K234047 | Automatic Registration | Brainlab AG | Orthopedic | 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 | Orthopedic | OLO |
| 03/08/2024 | K233438 | SleepStageML | Beacon Biosignals, Inc. | Neurology | OLZ |
| 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 | K233030 | BoneMRI | MRIguidance B.V | Radiology | QIH |
| 03/01/2024 | K231690 | iCAS-LV | HighRAD Ltd. | Radiology | QIH |
| 02/29/2024 | K231683 | inHEART Models | inHEART, SAS | Radiology | QIH |
| 02/29/2024 | K232765 | MAGNETOM Cima.X Fit | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 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 Systems Co., Ltd. | 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 |
| 02/05/2024 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz.ai, Inc. | Radiology | QIH |
| 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 Corporation | Radiology | IYN |
| 01/19/2024 | K233728 | SIGNA Champion | GE Healthcare (Tianjin) Company Limited | Radiology | LNH |
| 01/19/2024 | K232156 | Rapid ASPECTS (v3) | iSchemaView, Inc. | Radiology | POK |
| 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 | K233677 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | Radiology | KPS |
| 01/12/2024 | K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | QNP |
| 01/11/2024 | K232250 | SurgiCount+ System | Stryker Instruments | General and Plastic Surgery | PBZ |
| 01/08/2024 | K231324 | DASI Dimensions (V1.0) | DASI Simulations | Radiology | QIH |
| 01/08/2024 | K232412 | LungQ v3.0.0 | Thirona BV | Radiology | JAK |
| 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 | K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 12/22/2023 | K232479 | ART-Plan | TheraPanacea | Radiology | MUJ |
| 12/22/2023 | K231805 | qXR-LN | Qure.ai Technologies | Radiology | MYN |
| 12/21/2023 | K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 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 Healthcare Co., Ltd. | Radiology | LLZ |
| 12/18/2023 | K231587 | MAGNETOM Cima.X | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 12/18/2023 | K231929 | iQ-solutions | Sydney Neuroimaging Analysis Centre Pty Ltd | Radiology | QIH |
| 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 | K232231 | QP-Brain | Quibim S.L. | Radiology | QIH |
| 12/13/2023 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care Ltd. | Anesthesiology | PHZ |
| 12/11/2023 | K232096 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | Radiology | QIH |
| 12/08/2023 | K223757 | Bonelogic | Disior Ltd | Radiology | LLZ |
| 12/08/2023 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | Radiology | LLZ |
| 12/07/2023 | K232661 | Myocardial Strain Software Application | Circle Cardiovascular Imaging | Radiology | LLZ |
| 12/07/2023 | K232381 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
| 12/06/2023 | K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | 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 GmbH | 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 Solutions USA, Inc. | 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 Limited | Radiology | QIH |
| 11/14/2023 | K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 11/13/2023 | K232083 | BriefCase-Quantification | Aidoc Medical, Ltd. | Radiology | QIH |
| 11/13/2023 | K232257 | Clarius Bladder AI | Clarius Mobile Health Corp. | Radiology | QIH |
| 11/09/2023 | K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 11/09/2023 | K223754 | BraveCX | Bering Ltd | Radiology | QFM |
| 11/08/2023 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | Radiology | QIH |
| 11/08/2023 | K231765 | Contour ProtegeAI | MIM Software Inc. | Radiology | QKB |
| 11/07/2023 | K231966 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
| 11/07/2023 | K231989 | LOGIQ E10s, LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics, | 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 | K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Radiology | IYN |
| 10/30/2023 | K232751 | BriefCase-Triage | Aidoc Medical, Ltd. | Radiology | QAS |
| 10/30/2023 | K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
| 10/27/2023 | K230854 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
| 10/27/2023 | K232045 | MeVis Liver Suite | MeVis Medical Solutions AG | Radiology | JAK |
| 10/26/2023 | K232500 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | Radiology | IYN |
| 10/25/2023 | K230842 | SignalHF (IM008) | Implicity Inc. | Cardiovascular | QNL |
| 10/25/2023 | K232436 | Rapid SDH | iSchemaView, Inc. | Radiology | QAS |
| 10/23/2023 | K232305 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
| 10/23/2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 10/23/2023 | K231764 | Ultrasound System 1300 | BK Medical Aps | Radiology | IYN |
| 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 Systems Co., Ltd. | 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 Limited | Anesthesiology | QRG |
| 10/05/2023 | K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | Radiology | IYN |
| 10/05/2023 | K231001 | DeepTek CXR Analyzer v1.0 | DeepTek Medical Imaging Pvt Ltd | Radiology | MYN |
| 10/05/2023 | K232367 | cmAngio V1.0 | CureMetrix, Inc. | Radiology | QIH |
| 10/04/2023 | K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.AI Co., Ltd. | Radiology | QAS |
| 10/04/2023 | K232023 | Momentum Spine | Momentum Health Inc. | Physical Medicine | LDK |
| 10/04/2023 | K231398 | VUNO Med-DeepBrain | VUNO Inc. | Radiology | QIH |
| 10/03/2023 | K230085 | Lung-CAD | Imagen Technologies, Inc | Radiology | MYN |
| 10/03/2023 | K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 10/03/2023 | K232712 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
| 09/29/2023 | K230045 | HipCheck | Stryker Corp. | Radiology | QIH |
| 09/28/2023 | K231837 | Brainomix 360 Triage LVO | Brainomix Limited | Radiology | QAS |
| 09/28/2023 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | Cardiovascular | QYE |
| 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 | K223659 | Jazz | AI Medical AG | Radiology | LLZ |
| 09/22/2023 | K231767 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd. | Radiology | QAS |
| 09/22/2023 | K231384 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd. | Radiology | QAS |
| 09/22/2023 | K231149 | qXR-CTR | Qure.ai Technologies | Radiology | QIH |
| 09/21/2023 | K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc | Radiology | MYN |
| 09/19/2023 | K221309 | AI100 with Shonit | SigTuple Technologies Pvt. Ltd. | Hematology | JOY |
| 09/19/2023 | K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | Radiology | JAK |
| 09/14/2023 | K220034 | NEUROShield | In-Med Prognostics L3C | Radiology | LLZ |
| 09/13/2023 | K223811 | Lung-CAD | Imagen Technologies, Inc | Radiology | MYN |
| 09/12/2023 | K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation | Radiology | KPS |
| 09/12/2023 | K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | Radiology | JAA |
| 09/09/2023 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG | Neurology | HAW |
| 09/08/2023 | K222921 | Minuteful-kidney test | Healthy.io Ltd. | Clinical Chemistry | JIR |
| 09/08/2023 | K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | Radiology | QIH |
| 09/08/2023 | K231335 | Cleerly ISCHEMIA | Cleerly, Inc | Cardiovascular | QXZ |
| 09/08/2023 | K232686 | CorVista System | CorVista Health, Inc. | Cardiovascular | QXX |
| 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 Solutions USA, Inc. | 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 Corporation | 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 | Orthopedic | OLO |
| 07/27/2023 | K231195 | Brainomix 360 Triage ICH | Brainomix Limited | Radiology | QAS |
| 07/27/2023 | K230074 | Rapid Aneurysm Triage and Notification | iSchemaView, Inc. | Radiology | QFM |
| 07/26/2023 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | Cardiovascular | QNL |
| 07/26/2023 | K231572 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
| 07/25/2023 | K223473 | ME-APDS™; MAGENTIQ-COLO™ | Magentiq Eye LTD | Gastroenterology-Urology | QNP |
| 07/25/2023 | K230365 | Sonio Detect | Sonio | Radiology | IYN |
| 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 Healthcare Co., Ltd. | Radiology | QIH |
| 07/19/2023 | K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | Radiology | OEB |
| 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 Angio (1.0) | Brainlab AG | Radiology | QIH |
| 07/13/2023 | K223424 | Spine Auto Views | GE Medical Systems SCS | Radiology | JAK |
| 07/13/2023 | K223426 | ECHELON Synergy MRI system | FUJIFILM Healthcare Corporation | Radiology | LNH |
| 07/13/2023 | K231833 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. | Radiology | KPS |
| 07/12/2023 | K230823 | AusculThing ACC | AusculThing Oy | Cardiovascular | DQD |
| 07/10/2023 | K223724 | MOZI TPS | Manteia Technologies Co., Ltd | Radiology | MUJ |
| 07/07/2023 | K231668 | Spine CAMP™ (1.1) | Medical Metrics, Inc | Radiology | QIH |
| 07/03/2023 | K222745 | Axial3D Insight | Axial Medical Printing Limited | Radiology | QIH |
| 06/29/2023 | K230337 | EarliPoint | EarliTec Diagnostics, Inc. | Neurology | QPF |
| 06/22/2023 | K230497 | Bladder AI (AIBV01) | Exo Inc | Radiology | QIH |
| 06/20/2023 | K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty Ltd. | Radiology | LNH |
| 06/16/2023 | K223357 | EyeArt v2.2.0 | Eyenuk, Inc | Ophthalmic | PIB |
| 06/16/2023 | K223646 | IB Lab LAMA | IB Lab Gmbh | Radiology | QIH |
| 06/16/2023 | K223556 | DeepCatch | MEDICALIP Co., Ltd | Radiology | QIH |
| 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 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | GE Medical Systems, LLC | Radiology | QBS |
| 05/25/2023 | K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | Cardiovascular | QFJ |
| 05/23/2023 | K223504 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | Neurology | OMB |
| 05/23/2023 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | Radiology | QDQ |
| 05/19/2023 | K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - AI, Ltd. | Gastroenterology-Urology | QNP |
| 05/19/2023 | K212758 | Autoplaque | Cedars-Sinai Medical Center: AIM | Radiology | LLZ |
| 05/17/2023 | K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | 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 | K230082 | Auto Segmentation | GE Medical Systems, LLC | Radiology | QKB |
| 05/04/2023 | K223771 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | Radiology | IYN |
| 05/02/2023 | K230977 | SIS System | Surgical Information Sciences, Inc. | Radiology | QIH |
| 05/02/2023 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co.,Ltd. | Cardiovascular | QDA |
| 04/27/2023 | K223734 | ENT EM | Brainlab AG | Ear Nose & Throat | PGW |
| 04/27/2023 | K223212 | Precision DL | GE Healthcare | Radiology | KPS |
| 04/26/2023 | K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | Radiology | LLZ |
| 04/26/2023 | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | Cardiovascular | MXD |
| 04/25/2023 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | Radiology | QIH |
| 04/25/2023 | K230223 | iCAC Device | Bunkerhill, Inc. | Radiology | JAK |
| 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., LTD. | Radiology | IYN |
| 04/20/2023 | K223287 | Velacur | Sonic Incytes | Radiology | IYO |
| 04/20/2023 | K230807 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | Radiology | JAK |
| 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 B.V. | 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) Technology Co., Ltd | Radiology | QIH |
| 04/11/2023 | K223830 | Ultrasound System 2300 | BK Medical Aps | Radiology | IYN |
| 04/07/2023 | K230658 | SKOUT® system | Iterative Scopes Inc. | Gastroenterology-Urology | QNP |
| 04/07/2023 | K230575 | Limbus Contour | Limbus AI Inc. | Radiology | LLZ |
| 04/06/2023 | K223774 | Contour ProtégéAI | MIM Software Inc. | Radiology | QKB |
| 04/06/2023 | K222360 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions U.S.A. | Radiology | JAK |
| 04/06/2023 | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | 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 | K213272 | Formus Hip | Formus Labs, Ltd | Radiology | QIH |
| 03/31/2023 | K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | Radiology | IYO |
| 03/29/2023 | K222312 | RayStation 12A | Raysearch Laboratories AB (Publ) | Radiology | MUJ |
| 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 | K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-AI Pty Ltd | Radiology | QFM |
| 03/28/2023 | K223343 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutions USA Inc. | Radiology | LNH |
| 03/28/2023 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | Radiology | MYN |
| 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 | K223073 | AIio | AIio, Inc. | Gastroenterology-Urology | DRG |
| 03/17/2023 | K223443 | Viz AAA | Viz.ai, Inc. | Radiology | QFM |
| 03/17/2023 | K221772 | NeuroRPM | New Touch Digital Inc. | Neurology | GYD |
| 03/10/2023 | K223325 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
| 03/09/2023 | K223514 | Spectral Bone Marrow | GE Medical Systems, LLC | Radiology | JAK |
| 03/09/2023 | K221706 | AccuContour | Manteia Technologies Co., Ltd. | Radiology | QKB |
| 03/07/2023 | K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | Radiology | JAK |
| 03/03/2023 | K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | Radiology | JAK |
| 03/02/2023 | K222884 | Rapid NCCT Stroke | iSchemaView Inc. | Radiology | QAS |
| 03/02/2023 | K222176 | BoneView | Gleamer | Radiology | QBS |
| 03/01/2023 | K221680 | Xeleris V Processing and Review System | GE Healthcare | Radiology | LLZ |
| 02/24/2023 | DEN220063 | Caption Interpretation Automated Ejection Fraction Software | Caption Health, Inc | Radiology | QVD |
| 02/24/2023 | K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | Radiology | LLZ |
| 02/23/2023 | K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | Radiology | POK |
| 02/23/2023 | K222579 | Belun Sleep System BLS-10 | Belun Technology Company Limited | Anesthesiology | MNR |
| 02/22/2023 | K230197 | BoneMRI v1.6 | MRIguidance B.V | Radiology | QIH |
| 02/22/2023 | K230208 | Swoop® Portable MR Imaging System™ | Hyperfine, Inc. | Radiology | LNH |
| 02/17/2023 | DEN210022 | PMD-200 | Medasense Biometrics Ltd. | Anesthesiology | QVE |
| 02/16/2023 | K222755 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | Radiology | LNH |
| 02/16/2023 | K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK |
| 02/15/2023 | K222389 | ZEUS System | iRhythm Technologies, Inc. | Cardiovascular | DQK |
| 02/15/2023 | K223407 | Versana Essential | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
| 02/13/2023 | K223439 | SIGNA Victor | GE Healthcare (Tianjin) Company Limited | Radiology | LNH |
| 02/13/2023 | K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 02/06/2023 | K223296 | Videa Perio Assist | VideaHealth, Inc | Radiology | QIH |
| 02/02/2023 | K222803 | Oncospace | Oncospace, Inc. | Radiology | MUJ |
| 02/01/2023 | K223396 | Rapid RV/LV | iSchemaView Inc. | Radiology | QIH |
| 02/01/2023 | K230020 | BriefCase | Aidoc Medical, Ltd. | Radiology | QFM |
| 02/01/2023 | K222970 | LVivo IQS | DiA Imaging Analysis Ltd. | 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 Corp. | Radiology | QIH |
| 01/21/2023 | K223516 | VX1+ | Volta Medical | Cardiovascular | DQK |
| 01/18/2023 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging Inc. | 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 Nederlands B.V. | Radiology | LNH |
| 12/23/2022 | K214036 | AVIEW | Coreline Soft Co., Ltd. | Radiology | QIH |
| 12/22/2022 | K223311 | Philips CT 3500 | Philips Healthcare (Suzhou) Co., Ltd | Radiology | JAK |
| 12/16/2022 | K223268 | BrainInsight | Hyperfine, Inc. | Radiology | QIH |
| 12/16/2022 | K220928 | Overjet Calculus Assist | Overjet, Inc. | Radiology | MYN |
| 12/16/2022 | K222275 | Saige-Density | DeepHealth, Inc. | Radiology | QIH |
| 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 | K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | Radiology | POK |
| 11/22/2022 | K221716 | CINA | AVICENNA.AI | Radiology | QAS |
| 11/21/2022 | K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | 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 Solutions USA, Inc. | Radiology | QIH |
| 11/10/2022 | K220408 | AVIEW RT ACS | Coreline Soft Co., Ltd. | Radiology | QKB |
| 11/10/2022 | K221183 | AEYE-DS | AEYE Health, Inc. | Ophthalmic | PIB |
| 11/08/2022 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.AI Co., Ltd. | Radiology | QFM |
| 10/27/2022 | K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH |
| 10/25/2022 | K222070 | EndoNaut | Therenva SAS | Radiology | LLZ |
| 10/21/2022 | K223042 | Viz LVO ContaCT | Viz.Ai, Inc. | Radiology | QAS |
| 10/20/2022 | K222361 | AI-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 10/18/2022 | K221632 | Spine CAMP™ | Medical Metrics, Inc. | Radiology | QIH |
| 10/14/2022 | K221305 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc | Radiology | QKB |
| 10/14/2022 | K213857 | HeartFlow Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
| 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 | Ear Nose & Throat | BXQ |
| 09/30/2022 | K211611 | QIR Suite | CASIS Cardiac Simulation & Imaging Software | 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, Inc. | Radiology | MYN |
| 09/13/2022 | K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 09/12/2022 | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | Radiology | JAK |
| 09/12/2022 | K221456 | Rapid ICH | iSchemaView Inc. | Radiology | QAS |
| 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 Solutions USA Inc. | Radiology | MUJ |
| 09/06/2022 | K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | Radiology | LNH |
| 09/01/2022 | K221241 | DrAid for Radiology v1 | VinBrain Joint Stock Company | 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 | K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | Cardiovascular | MXD |
| 08/25/2022 | K211841 | MRI Planner | Spectronic Medical AB | Radiology | MUJ |
| 08/24/2022 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | Radiology | QKB |
| 08/22/2022 | K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 08/19/2022 | K222172 | MI View&GO | Siemens Medical Solutions USA, Inc. | 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 GmBh | 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 | QKB |
| 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 Corporation | Radiology | JAK |
| 07/28/2022 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging Inc | 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 Solutions S.A. | Radiology | LLZ |
| 07/22/2022 | K220882 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and | Radiology | IYN |
| 07/22/2022 | K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | QIH |
| 07/20/2022 | K220956 | Libby Echo:Prio | Dyad Medical, Inc | Radiology | QIH |
| 07/19/2022 | K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | Cardiovascular | DQK |
| 07/19/2022 | K220815 | BrainInsight | Hyperfine, 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 |
| 07/18/2022 | K221148 | Vivid iq | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | Radiology | IYN |
| 07/18/2022 | K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
| 07/15/2022 | K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN |
| 07/14/2022 | K221203 | AHI System | Fifth Eye Inc. | Cardiovascular | QNV |
| 07/13/2022 | K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 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., Ltd. | Radiology | IYN |
| 06/27/2022 | K220848 | Venue Fit | GE Medical Systems | Radiology | IYN |
| 06/27/2022 | K220851 | Venue | GE Medical Systems | Radiology | IYN |
| 06/24/2022 | K220575 | MAGNETOM Free.Max, MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 06/23/2022 | K220497 | CoLumbo | Smart Soft Healthcare AD | Radiology | QIH |
| 06/21/2022 | K220800 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | Radiology | IYN |
| 06/17/2022 | K220813 | ART-PLAN | TheraPanacea | Radiology | QKB |
| 06/17/2022 | K221463 | ElucidVivo A.3 | Elucid Bioimaging Inc. | Radiology | LLZ |
| 06/17/2022 | K213037 | IDx-DR v2.3 | Digital Diagnostics Inc. | Ophthalmic | PIB |
| 06/16/2022 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 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 (GE Healthcare) | Radiology | LNH |
| 06/06/2022 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | 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 | K220766 | eMurmur Heart AI | CSD Labs GmbH | Cardiovascular | DQD |
| 05/31/2022 | K221248 | Rapid LVO | iSchemaView, Inc. | Radiology | QAS |
| 05/25/2022 | K220416 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
| 05/17/2022 | K221219 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 05/17/2022 | K220499 | Rapid PE Triage and Notification (PETN) | iSchemaView Inc. | Radiology | QAS |
| 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 Nederland B.V. | Radiology | LNH |
| 05/13/2022 | K221106 | Quantib Prostate | Quantib BV | Radiology | LLZ |
| 05/13/2022 | K220589 | MAGNETOM Skyra Fit | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 05/12/2022 | K220105 | Saige-Dx | DeepHealth, Inc. | Radiology | QDQ |
| 05/11/2022 | K220446 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics, | 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 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs Ltd. | Hematology | JOY |
| 05/03/2022 | K212915 | MVision AI Segmentation | MVision AI | Radiology | QKB |
| 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 Solutions USA Inc. | 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 (Suzhou) Co., Ltd. | Radiology | JAK |
| 04/26/2022 | K212662 | AliveCor QT Service | AliveCor, Inc. | Cardiovascular | DQK |
| 04/26/2022 | K213886 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
| 04/22/2022 | K213944 | HealthOST | NanoxAI Ltd. | Radiology | JAK |
| 04/21/2022 | K213795 | Videa Caries Assist | VideaHealth, Inc | Radiology | MYN |
| 04/15/2022 | K220141 | RayStation 11B | RaySearch Laboratories AB (publ) | Radiology | MUJ |
| 04/15/2022 | K213706 | AI-Rad Companion Brain MR | Siemens Healthcare GmBh | Radiology | QIH |
| 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 Corporation | Radiology | LNH |
| 04/06/2022 | K203783 | ClariPulmo | ClariPi Inc. | Radiology | LLZ |
| 04/05/2022 | K214081 | MRCAT Head & Neck | Philips Oy | Radiology | MUJ |
| 04/05/2022 | K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 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 Solutions USA, Inc. | 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 Corporation | 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, Inc. | 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 Solutions USA, Inc. | Radiology | LNH |
| 02/24/2022 | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-AI | Radiology | QFM |
| 02/18/2022 | K213319 | Viz ANEURYSM, Viz ANX | Viz.ai, Inc. | Radiology | QFM |
| 02/18/2022 | K213999 | Deep Learning Image Reconstruction | GE Medical Systems | Radiology | JAK |
| 02/11/2022 | K213603 | SIGNA Artist Evo | GE Healthcare(Tianjin) Company Limited | 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 Corporation | Radiology | JAK |
| 02/03/2022 | K213976 | Contour ProtegeAI | MIM Software Inc. | Radiology | QKB |
| 01/28/2022 | K203260 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | Radiology | QAS |
| 01/24/2022 | K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | Radiology | IYN |
| 01/20/2022 | K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 01/20/2022 | K213668 | SIGNA Hero | GE Healthcare (GE Medical Systems, LLC) | Radiology | LNH |
| 01/19/2022 | K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | Radiology | QIH |
| 01/19/2022 | K212012 | Follicle Clarity | Cycle Clarity | Radiology | QIH |
| 01/16/2022 | K211980 | SIGNA Prime | GE Healthcare (Tianjin) Company Limited | 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 Nederland, B.V. | Radiology | JAK |
| 01/12/2022 | K212005 | UNiD Spine Analyzer | MEDICREA International, Inc. | Radiology | LLZ |
| 01/07/2022 | K211443 | AIBOLIT 3D+ | AIbolit Technologies, LLC | Radiology | LLZ |
| 01/06/2022 | K213544 | TOMTEC-ARENA | TOMTEC Imaging Systems GmbH | Radiology | QIH |
| 12/29/2021 | K213776 | LiverSmart | Resonance Health Analysis Services Pty Ltd | Radiology | PCS |
| 12/22/2021 | K202404 | BoneMRI | MRIguidance B.V | Radiology | QIH |
| 12/21/2021 | K210670 | BU-CAD | TaiHao Medical Inc. | Radiology | QDQ |
| 12/21/2021 | K212690 | qXR-BT | Qure.ai Technologies | Radiology | QIH |
| 12/20/2021 | K213275 | EchoGo Core (2.0) | Ultromics Limited | Radiology | QIH |
| 12/16/2021 | K213628 | VBrain | Vysioneer Inc. | Radiology | QKB |
| 12/16/2021 | K212616 | Koios DS | Koios Medical, Inc. | Radiology | POK |
| 12/15/2021 | K213155 | RT-Mind-AI | MedMind Technology Co., Ltd. | Radiology | QKB |
| 12/15/2021 | K211803 | HealthPPT | Zebra Medical Vision Ltd. | Radiology | QFM |
| 12/09/2021 | K212466 | LVivo Seamless V2.0 | DiA Imaging Analysis Ltd | Radiology | QIH |
| 12/06/2021 | K213096 | Al-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 12/03/2021 | K212219 | AHI System | Fifth Eye Inc. | Cardiovascular | QNV |
| 12/01/2021 | K213305 | Vantage Fortian 1.5T | Canon Medical Systems Corporation | Radiology | LNH |
| 11/26/2021 | K211541 | MammoScreen 2.0 | Therapixel | Radiology | QDQ |
| 11/19/2021 | K211326 | EndoScreener | Chengdu Wision Medical Device Co., LTD. | Gastroenterology-Urology | QNP |
| 11/19/2021 | K210831 | OnQ Neuro | CorTechs Labs, Inc. | Radiology | QIH |
| 11/17/2021 | K211678 | Lunit INSIGHT MMG | Lunit Inc. | Radiology | QDQ |
| 11/17/2021 | K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | Radiology | LNH |
| 11/17/2021 | K212336 | Soteria.AI | Omega Medical Imaging, LLC | Radiology | OWB |
| 11/16/2021 | K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | Radiology | IYN |
| 11/15/2021 | K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 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 | K212516 | IRNF App | Apple Inc. | Cardiovascular | QDB |
| 10/22/2021 | K210807 | FlightPlan for Liver | GE Medical Systems SCS | Radiology | LLZ |
| 10/20/2021 | K210632 | Contour ProtegeAI | MIM Software Inc. | Radiology | QKB |
| 10/14/2021 | K210999 | SwiftMR | AIRS Medical Inc. | Radiology | LLZ |
| 10/14/2021 | K212261 | StrokeSENS LVO | Circle Neurovascular Imaging, Inc | Radiology | QAS |
| 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 Corporation | 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 | K210438 | Versana Premier | GE Medical Systems Ultrasound And Primary Care Diagnostics | Radiology | IYN |
| 09/10/2021 | K203785 | ClariSIGMAM | ClariPI Inc. | Radiology | QIH |
| 09/10/2021 | K211828 | Aquilion Exceed LB | Canon Medical Systems Corporation | Radiology | JAK |
| 09/09/2021 | K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 09/08/2021 | K203555 | AmCAD-UT | AmCad BioMed Corporation | Radiology | QIH |
| 09/08/2021 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | Radiology | IYN |
| 09/08/2021 | K211945 | V8 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | Radiology | IYN |
| 09/08/2021 | DEN200030 | Feops HEARTguide | Feops NV | Cardiovascular | QQI |
| 09/08/2021 | K211867 | RayStation 11.0 | RaySearch Laboratories AB (publ) | Radiology | MUJ |
| 09/02/2021 | K211881 | AI Segmentation Varian | Medical Systems, Inc. | Radiology | MUJ |
| 08/31/2021 | K212383 | EndoNaut | Therenva SAS | Radiology | OWB |
| 08/31/2021 | K201560 | Auto Lung Nodule Detection | Samsung Electronics Co.,Ltd. | Radiology | MYN |
| 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 Medical Ltd | Radiology | LLZ |
| 08/12/2021 | K211179 | InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | Radiology | QAS |
| 08/11/2021 | K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK |
| 08/06/2021 | K211764 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 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 | K211222 | qER-Quant | Qure.ai Technologies | Radiology | QIH |
| 07/30/2021 | K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA Inc. | Radiology | MUJ |
| 07/27/2021 | K211279 | Volpara Imaging Software | Volpara Health Technologies Limited | Radiology | LLZ |
| 07/27/2021 | K210791 | Us2.v1 | eko.ai Pte. Ltd. d/b/a Us2.ai | Radiology | QIH |
| 07/27/2021 | K211655 | aPROMISE | EXINI Diagnostics AB | Radiology | LLZ |
| 07/27/2021 | K212074 | ClariCT.AI | ClariPi Inc. | Radiology | LLZ |
| 07/23/2021 | K211951 | GI Genius | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology | QNP |
| 07/20/2021 | K210719 | Change Healthcare Anatomical AI | Change Healthcare Canada Company | Radiology | QIH |
| 07/20/2021 | K211906 | Vital Signs | Oxehealth Limited | Cardiovascular | QME |
| 07/20/2021 | K210666 | Chest-CAD | Imagen Technologies, Inc | Radiology | MYN |
| 07/12/2021 | K211506 | PowerLook Density Assessment Software 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 Solutions USA, Inc. | Radiology | LNH |
| 06/29/2021 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (publ) | Radiology | MUJ |
| 06/17/2021 | K203514 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | Radiology | JAK |
| 06/16/2021 | K210034 | EnsoSleep | EnsoData, Inc. | Neurology | OLZ |
| 06/16/2021 | K202718 | Qmenta Care Platform Family | Mint Labs, Inc., D/B/A. QMENTA | Radiology | LLZ |
| 06/11/2021 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Cardiovascular | MXD |
| 06/10/2021 | K203629 | IDx-DR | Digital Diagnostics Inc. | Ophthalmic | PIB |
| 06/10/2021 | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. | Radiology | QIH |
| 06/08/2021 | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | Abbott Medical | Cardiovascular | NQQ |
| 06/02/2021 | K210404 | Transpara 1.7.0 | ScreenPoint Medical B.V. | Radiology | QDQ |
| 06/02/2021 | DEN200069 | Cognoa Asd Diagnosis Aid | Cognoa, Inc. | Neurology | QPF |
| 05/21/2021 | K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | Cardiovascular | DQK |
| 05/19/2021 | K210237 | CINA CHEST | Avicenna.AI | Radiology | QAS |
| 05/19/2021 | K210187 | Overjet Dental Assist | Overjet, Inc. | Radiology | LLZ |
| 05/14/2021 | K201034 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 05/13/2021 | K211118 | SIGNA 7.0T | GE Medical Systems, LLC | Radiology | LNH |
| 05/13/2021 | K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology | IYN |
| 04/30/2021 | K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co.,Ltd. | 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 Corporation | Radiology | KPS |
| 04/21/2021 | K210556 | Preview Shoulder | Genesis Software Innovations | Radiology | QIH |
| 04/20/2021 | K203610 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | 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 Intelligence - AI, Ltd. | 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 Ltd. | Cardiovascular | QOK |
| 03/31/2021 | K203258 | syngo.CT Lung CAD (Version VD20) | Siemens Healthcare GmbH | Radiology | OEB |
| 03/31/2021 | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with syngo MR XA31A | Siemens Medical Solutions USA, Inc. | Radiology | LNH |
| 03/31/2021 | K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | Radiology | LLZ |
| 03/26/2021 | DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | Cardiovascular | QME |
| 03/24/2021 | K203225 | AquilionONE(TSX‐306A/3)V10.4withSpectralImagingSystem | CanonMedicalSystemsCorporation | 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 | K203822 | ProFound AI Software V3.0 | ICAD Inc. | Radiology | QDQ |
| 03/12/2021 | K202284 | Oncospace | Oncospace, Inc. | Radiology | MUJ |
| 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 Corporation | 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 Imaging AI, Inc. | General and Plastic Surgery | NQQ |
| 02/19/2021 | K202212 | Truplan | Circle Cardiovascular Imaging Inc. | 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 Intelligence Co., Ltd. | Radiology | QFM |
| 01/15/2021 | K202767 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | 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 Corporation | Radiology | JAK |
| 01/11/2021 | P200003 | Imagio Breast Imaging System | Seno Medical Instruments, Inc. | 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 Corporation | 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 Analysis Services Pty Ltd. | 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 Corporation | Radiology | JAK |
| 11/20/2020 | K193287 | CorInsights MRI | ADM Diagnostics | Radiology | LLZ |
| 11/18/2020 | K201019 | Genius AI Detection | Hologic, Inc. | Radiology | QDQ |
| 11/18/2020 | K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | Radiology | LLZ |
| 11/17/2020 | K193306 | PROView | GE Medical Systems SCS | Radiology | LLZ |
| 11/12/2020 | K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | Radiology | JAK |
| 11/12/2020 | K201985 | KardiaAI | AliveCor, Inc. | Cardiovascular | DQK |
| 11/06/2020 | K200750 | Neuro.Al Algorithm | TeraRecon, Inc. | Radiology | LLZ |
| 11/06/2020 | K193562 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | Radiology | QKB |
| 10/30/2020 | K200323 | Autocontour | Radformation, Inc. | Radiology | QKB |
| 10/30/2020 | K202013 | WRDensity by Whiterabbit.ai | Whiterabbit.ai Inc. | Radiology | QIH |
| 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 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | Hematology | JOY |
| 10/16/2020 | K201710 | A View LCS | Coreline Soft Co., Ltd. | Radiology | LLZ |
| 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 Ab (Publ) | Radiology | MUJ |
| 09/18/2020 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | LLZ |
| 09/18/2020 | K201992 | Caption Guidance | Caption Health | Radiology | QJU |
| 09/16/2020 | K201298 | VX1 | Volta Medical | Cardiovascular | DQK |
| 09/16/2020 | K201369 | AVA (Augmented Vascular Analysis) | See-Mode Technologies Pte. Ltd. | Radiology | LLZ |
| 09/15/2020 | K192665 | Accelerate Pheno System, Accelerate Phenotest Bc Kit | Accelerate Diagnostics, Inc. | Microbiology | PRH |
| 09/09/2020 | K200708 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
| 09/09/2020 | K200851 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Radiology | IYN |
| 09/06/2020 | K201841 | EyeBOX | Oculogica, Inc. | Neurology | QEA |
| 09/04/2020 | K202238 | SIGNA Artist | GE Healthcare (Tianjin) Company Limited | Radiology | LNH |
| 09/02/2020 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant Inc. | Cardiovascular | MLO |
| 08/26/2020 | K200714 | AVIEW | Coreline Soft Co., Ltd. | Radiology | LLZ |
| 08/26/2020 | K201020 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
| 08/14/2020 | K201632 | Tomtec-Arena | Tomtec Imaging Systems Gmbh | Radiology | LLZ |
| 08/13/2020 | K201444 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | Radiology | MUJ |
| 08/13/2020 | K201232 | Limbus Contour | Limbus Ai Inc. | Radiology | LLZ |
| 08/07/2020 | K200990 | Vida|Vision | Vida Diagnostics Inc. | Radiology | JAK |
| 08/07/2020 | K201310 | Accipiolx | MaxQ Al Ltd. | Radiology | QAS |
| 08/04/2020 | K193210 | HYPER DLR | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | KPS |
| 08/03/2020 | K200667 | EyeArt | Eyenuk, Inc | Ophthalmic | PIB |
| 07/30/2020 | K193283 | AI-Rad Companion Prostate MR | Siemens Medical Solutions USA Inc | Radiology | QIH |
| 07/30/2020 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | Radiology | QBS |
| 07/23/2020 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | 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 Ultrasound and Primary Care Diagnostics, LLC | 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 Corporation | Radiology | LNH |
| 07/10/2020 | K192969 | Ezra Plexo Software | Ezra AI Inc. | Radiology | QIH |
| 07/10/2020 | K193294 | AI-Rad Companion Engine | Siemens Medical Solutions USA, Inc. | Radiology | LLZ |
| 07/09/2020 | K200941 | Rapid LVO | iSchemaView, Inc. | Radiology | QAS |
| 07/06/2020 | K193073 | Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | JAK |
| 07/02/2020 | K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co.,Ltd. | Radiology | OEB |
| 07/02/2020 | K193252 | Contour ProtégéAI | MIM Software, Inc. | Radiology | QKB |
| 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 Solutions USA, Inc. | 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 Healthcare Co., Ltd. | Radiology | QIH |
| 05/12/2020 | K192901 | HealthVCF | Zebra Medical Vision Ltd. | Radiology | QFM |
| 05/05/2020 | K193176 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | LNH |
| 05/05/2020 | K193220 | AVIEW LCS | Coreline Soft Co., Ltd | Radiology | LLZ |
| 05/01/2020 | K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | Radiology | IYN |
| 04/21/2020 | K193351 | NinesAI | Nines, Inc. | Radiology | QAS |
| 04/16/2020 | K200755 | Caption Guidance | Caption Health, Inc. | Radiology | QJU |
| 04/13/2020 | K192167 | CuraRad-ICH | CuraCloud Corp. | Radiology | QAS |
| 04/10/2020 | K193282 | Signa Premier | GE Healthcare (GE Medical Systems, LLC) | Radiology | LNH |
| 04/08/2020 | K193300 | AIMI-Triage CXR PTX | RADLogics, Inc. | Radiology | QFM |
| 03/31/2020 | K193087 | Rapid ICH | ISchemaView Incorporated | Radiology | QAS |
| 03/26/2020 | K192732 | Bodyguardian Remote Monitoring System | Preventice Technologies, Inc. | 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 | K193281 | Hepatic VCAR | GE Medical Systems SCS | Radiology | JAK |
| 03/20/2020 | K200036 | AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. | Cardiovascular | DPS |
| 03/18/2020 | K193658 | Viz ICH | Viz.Ai, Inc. | Radiology | QAS |
| 03/16/2020 | K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 03/12/2020 | K192388 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | Radiology | IYN |
| 03/09/2020 | K193216 | Syngo.CT Lung CAD | Siemens Medical Solutions, Inc | Radiology | OEB |
| 03/09/2020 | K192574 | Vantage Galan 3T, MRT-3020, V6.0 With AiCE Reconstruction Processing Unit For MR | Canon Medical Systems Corporation | Radiology | LNH |
| 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 Limited | Radiology | QFM |
| 02/28/2020 | K191928 | AccuContour | Xiamen Manteia Technology Ltd. | Radiology | QKB |
| 02/28/2020 | K192962 | icobrain-ctp | icometrix NV | Radiology | LLZ |
| 02/21/2020 | K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-I | Canon Medical Systems Corporation | 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 Solutions USA, Inc. | Radiology | KPS |
| 02/13/2020 | K192828 | Aquilion ONE (TSX-306A/3) V10.0 With Spectral Imaging System | Canon Medical Systems Corporation | Radiology | JAK |
| 02/12/2020 | K193178 | Biograph Horizon PET/CT | Siemens Medical Solution USA, Inc. | Radiology | KPS |
| 02/10/2020 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. | Radiology | IYE |
| 02/07/2020 | DEN190040 | Caption Guidance | Bay Labs, Inc. | Radiology | QJU |
| 01/24/2020 | K193109 | MRCAT Brain | Philips Medical Systems MR Finland | 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 Systems, Co., Ltd. | Radiology | JAK |
| 01/15/2020 | K192004 | Eko Analysis Software | Eko Devices Inc | Cardiovascular | MWI |
| 01/15/2020 | K191125 | ADAS 3D | Galgo Medical S.L | Radiology | LLZ |
| 01/02/2020 | K183089 | Air Next | NuvoAir AB | Anesthesiology | BZG |
| 12/20/2019 | K191647 | Qlab Advanced Quantification Software | Philips Healthcare | Radiology | QIH |
| 12/20/2019 | K192383 | BriefCase | Aidoc Medical, Ltd. | Radiology | QAS |
| 12/17/2019 | K192763 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 12/13/2019 | K192531 | QyScore Software | Qynapse | Radiology | LLZ |
| 12/13/2019 | K193170 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | Radiology | JAK |
| 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 Ltd. | Radiology | QFM |
| 11/25/2019 | K190529 | SOZO | ImpediMed Limited | Gastroenterology-Urology | QJB |
| 11/19/2019 | K191278 | RSI-MRI+ | Multimodal Imaging Services Corporation (Dba HealthLytix) | Radiology | LLZ |
| 11/13/2019 | K191171 | EchoGo Core | Ultromics Ltd. | Radiology | QIH |
| 11/07/2019 | K191026 | MEDIP PRO | MEDICAL IP 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. | General and Plastic Surgery | 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 Incorporated | Radiology | LLZ |
| 10/16/2019 | K191493 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics Ltd. | 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, LLC | Radiology | JAA |
| 09/18/2019 | K192065 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | Radiology | MUJ |
| 09/16/2019 | K191688 | SubtleMR | Subtle Medical Inc. | Radiology | LLZ |
| 09/13/2019 | K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | Radiology | LLZ |
| 09/11/2019 | K183370 | PeraMobile and PeraWatch | PeraHealth, Inc. | Cardiovascular | MWI |
| 09/11/2019 | K190815 | Brainscope TBI | BrainScope Company, Inc. | Neurology | PIW |
| 09/10/2019 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | Radiology | JAK |
| 09/04/2019 | K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | Neurology | GXY |
| 08/29/2019 | K183489 | D2P | 3D Systems, Inc. | Radiology | LLZ |
| 08/29/2019 | K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | Radiology | IYN |
| 08/23/2019 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | Cardiovascular | DQK |
| 08/15/2019 | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte. Ltd | Cardiovascular | PLB |
| 08/15/2019 | K190925 | HeartfFow FFRct Analysis | HeartFlow, Inc. | Cardiovascular | PJA |
| 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 Solutions USA, Inc. | 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 AB (Publ) | Radiology | MUJ |
| 07/05/2019 | K182901 | Aquilion Precision (TSX-304A/1 And /2) V8.8 With AiCE | Canon Medical Systems Corporation | Radiology | JAK |
| 07/03/2019 | K190442 | Koios DS For Breast | Koios Medical, Inc. | Radiology | POK |
| 06/27/2019 | K190017 | Livermultiscan (LMSv3) | Perspectum Diagnostics Ltd | Radiology | LNH |
| 06/25/2019 | K191194 | CLARUS | Carl Zeiss Meditec, Inc | Ophthalmic | QER |
| 06/19/2019 | K190387 | Raystation | Raysearch Laboratories Ab (Publ) | 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 Corporation | 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 Monitoring Platform, Acumen Hypotension Prediction Index, Hemosphere Advanced Monitoring Platform - Pressure | Edwards Lifeciences, LLC | Cardiovascular | QAQ |
| 05/15/2019 | K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems AG | 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 Sciences, Inc. | 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 Pte. Ltd. | 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 | General Hospital | NDC |
| 02/01/2019 | K183272 | AI Rad Companion (Engine) | Siemens Medical Solutions USA, Inc. | 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 Ltd | Radiology | LLZ |
| 12/28/2018 | DEN170091 | EyeBOX | Oculogica, Inc. | Neurology | QEA |
| 12/28/2018 | K180867 | AmCAD-UO | AmCad BioMed Corporation | Radiology | LLZ |
| 12/27/2018 | K182130 | ISchemaView RAPID | ISchemaView, Inc. | Radiology | LLZ |
| 12/27/2018 | K182564 | Quantib ND | Quantib BV | 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 | K173749 | AMRA Profiler | AMRA Medical AB | Radiology | LNH |
| 12/06/2018 | K182373 | PowerLook Tomo Detection V2 Software | ICAD Inc. | Radiology | QDQ |
| 12/06/2018 | K182035 | FFRct v2.18 | HeartFlow, Inc. | Cardiovascular | PJA |
| 11/30/2018 | K182218 | FerriSmart Analysis System | Resonance Health Analysis Service Pty Ltd. | Radiology | PCS |
| 11/30/2018 | K182336 | SubtlePET | Subtle Medical, Inc. | Radiology | KPS |
| 11/29/2018 | K182181 | Persyst 14 EEG Review And Analysis Software | Persyst Development Corporation | 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 Electronics., Ltd. | 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. | General and Plastic Surgery | NQQ |
| 10/26/2018 | K182177 | Accipiolx | MaxQ-Al Ltd. | Radiology | QAS |
| 10/25/2018 | K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | 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 Technologies, LLC | Neurology | GXY |
| 09/28/2018 | K173872 | FibriCheck | Qompium NV | Cardiovascular | DXH |
| 09/28/2018 | K181771 | RightEye Vision System | RightEye, LLC | Ophthalmic | GWN |
| 09/21/2018 | K182310 | Volpara Imaging Software | Volpara Health Technologies Limited | Radiology | LLZ |
| 08/29/2018 | K181502 | Zio AT ECG Monitoring System, Zeus System | IRhythm Technologies, Inc. | Cardiovascular | DQK |
| 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 | Orthopedic | 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 | General and Plastic Surgery | NAY |
| 05/24/2018 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | Radiology | QBS |
| 05/14/2018 | K173810 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics, Ltd. | Radiology | IYN |
| 05/14/2018 | K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | Radiology | IYN |
| 05/02/2018 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | 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 | Gastroenterology-Urology | 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. | Pathology | OIW |
| 03/09/2018 | K173939 | Quantib Brain | Quantib BV | Radiology | LLZ |
| 03/08/2018 | K173605 | IQMR | Medic Vision - Imaging Solutions Ltd | 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 Technologies, Ltd | 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, LLC | 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.,Ltd. | 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 Corp. | 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 | Gastroenterology-Urology | OBH |
| 08/01/2017 | K171315 | Advanced RBC Application | Cella Vision AB | Hematology | JOY |
| 07/19/2017 | DEN170022 | QuantX | Quantitative Insights, Inc | Radiology | POK |
| 06/26/2017 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | Cardiovascular | DPS |
| 06/09/2017 | K170747 | Syngo Application Software | Siemens Medical Solutions, USA, Inc. | Radiology | LLZ |
| 06/07/2017 | K170250 | SmartTarget | SmarTarget, Ltd. | Radiology | LLZ |
| 05/24/2017 | K170172 | UNiD Spine Analyzer | Medicrea International | Radiology | LLZ |
| 05/11/2017 | K163622 | Lung Vision | Body Vision Medical Ltd. | Radiology | LLZ |
| 05/05/2017 | K163665 | MATRx Plus | Zephyr Sleep Technologies | Anesthesiology | MNR |
| 04/26/2017 | K170069 | AmCAD-UV | AmCad BioMed Corporation | Radiology | LLZ |
| 04/06/2017 | DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23andMe, Inc. | Hematology | PTA |
| 03/31/2017 | K162627 | EnsoSleep | EnsoData, Inc. | Neurology | OLZ |
| 02/23/2017 | K162855 | Reveal LINQ | Medtronic, Inc. | Cardiovascular | MXD |
| 02/14/2017 | K162830 | SIS Software | Surgical Information Sciences, Inc. | 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 Inc. | Radiology | LLZ |
| 12/07/2016 | K161322 | CT CoPilot | Zepmed, LLC | Radiology | LLZ |
| 11/30/2016 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | Radiology | IYN |
| 11/30/2016 | K161834 | One Drop Blood Glucose Monitoring System | AgaMatrix Inc. | Clinical Chemistry | NBW |
| 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 Inc. | Neurology | PIW |
| 09/19/2016 | K161625 | PixelShine | AlgoMedica | Radiology | LLZ |
| 09/09/2016 | K161201 | ClearRead CT | Riverain Technologies, LLC | Radiology | OEB |
| 08/24/2016 | K161772 | FFRct v2.0 | HeartFlow, Inc. | Cardiovascular | PJA |
| 08/09/2016 | K161148 | Icobrain | Icometrix | Radiology | LLZ |
| 08/05/2016 | K160338 | Triton System | Gauss Surgical Inc. | General and Plastic Surgery | 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 Ltd. | 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, Inc. | Neurology | PIW |
| 04/24/2015 | K142918 | EndoTool SubQ | Monarch Medical Technologies | General Hospital | NDC |
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| 11/17/2014 | DEN140025 | BrainScope Ahead 100 | BrainScope Company, Inc. | 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 Cardiovascular Imaging Inc | Radiology | LLZ |
| 04/22/2014 | K133649 | Hepatic VCAR | GE Medical Systems SCS | Radiology | JAK |
| 01/24/2014 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | Radiology | KPR |
| 11/21/2013 | K130831 | MALDI Biotyper CA (MBT-CA) System | Bruker Daltonics, Inc. | Microbiology | PEX |
| 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 | K123526 | ClearRead +Confirm | Riverain Technologies | Radiology | LLZ |
| 05/17/2012 | K120489 | Tissue of Origin Test Kit FFPE | Pathwork Diagnostics, Inc. | Pathology | OIW |
| 04/13/2012 | K120161 | AlphaPoint Imaging Software | RadLogics, Inc. | Radiology | LLZ |
| 12/28/2011 | K111776 | DeltaView Model 2.1 | Riverain Medical Group,Llc | Radiology | LLZ |
| 09/16/2011 | K102778 | CellaVision® DM1200 with the body fluid application | CellaVision AB | Hematology | JOY |
| 06/08/2010 | K092967 | Pathwork Tissue Of Origin Test Kit-Ffpe | Pathwork Diagnostics | Pathology | OIW |
| 05/12/2010 | K092116 | EasyCell | Medica Corporation | Hematology | JOY |
| 12/05/2008 | K080595 | CellaVision DM96 with the body fluid application | Cella Vision AB | Hematology | JOY |
| 09/12/2008 | K082483 | Quantra | Hologic, Inc. | Radiology | LLZ |
| 07/30/2008 | K080896 | Pathwork Tissue of Origin Test | Pathwork Diagnostics Inc. | Pathology | OIW |
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| 02/10/2004 | K033840 | CellaVision DM96 Automatic Hematology Analyzer | Cella Vision AB | Hematology | JOY |
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*Non-FDA publicly available resources:
- Medical AI Evaluation Database (from “How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals,” Wu, E., et al, Nature Medicine, 27, 582-584 (2021))
- A.I.-based algorithms (The Medical Futurist)
- AI Tools database (STAT) (Excel-22KB)
- Supplementary Appendix to “Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20),” Muehlematter UJ, et al., Lancet Digital Health 2021 https://doi.org/10.1016/S2589-7500(20)30292-2. (PDF-856KB)
- AI Central (American College of Radiology)
Note: The FDA has not verified the information that may appear in these resources.