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  1. Software as a Medical Device (SaMD)

Artificial Intelligence-Enabled Medical Devices

The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate artificial intelligence (AI).

The AI-Enabled Medical Device List is a resource intended to identify AI-enabled medical devices that are authorized for marketing in the United States. Digital health innovators can refer to this list to gain insights into the current device landscape and regulatory expectations, which can help foster innovation and ensure public safety. This list can also provide transparency for healthcare providers and patients to clearly identify when medical devices use AI technologies.  

Contents of the AI-Enabled Medical Devices List:

  • The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the device’s overall safety and effectiveness, which includes an evaluation of study appropriateness for the device’s intended use and technological characteristics.
  • A direct link to the FDA’s database entry of an AI-enabled medical device is provided. The database entry contains releasable information, such as summaries of safety and effectiveness. Note, the summaries are not all inclusive and do not include most of the information that may be submitted in an application.
  • The list is not a comprehensive resource of AI-enabled medical devices. Instead, the list includes AI-enabled medical devices that were identified primarily based on the use of AI-related terms in the summary descriptions of their marketing authorization document and/or the device’s classification. The set of AI terms is based on the FDA Digital Health and Artificial Intelligence Glossary.
  • To support transparency in the use of modern AI technologies, the FDA will explore methods to identify and tag medical devices that incorporate foundation models encompassing a wide range of AI systems, from large language models (LLMs) to multimodal architectures. This identification will help innovators, healthcare providers, and patients recognize when LLM-based functionality is present in a medical device. To facilitate the FDA’s development of methods to identify AI-enabled medical devices more easily, including identifying those devices incorporating LLM-based functionality in a future update of this list, sponsors are encouraged to include appropriate information in their public summaries.

This list will continue to be updated periodically. AI-enabled medical devices that have received authorization but for which decision summaries have not been published within the data collection period will be incorporated into a subsequent update.

Send questions or feedback on this list to digitalhealth@fda.hhs.gov.

AI-Enabled Medical Devices List

Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.

Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA's publicly available information.

Download a CSV File Download an Excel File Save as XML File*

*To save the XML file, right click and save the file to your computer and open in the appropriate program.

Date of Final DecisionSubmission NumberDeviceCompanyPanel (Lead)Primary Product Code
12/30/2025K253532TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.RadiologyQIH
12/23/2025K252379AIR Recon DLGe Medical Systems, LLCRadiologyLNH
12/23/2025K253091ART-Plan+ (v3.1.0)Therapanacea SasRadiologyMUJ
12/22/2025K252856PeekMed webPeek Health, S.A.RadiologyQIH
12/22/2025K253664SKOUT systemIterative HealthGastroenterology-UrologyQNP
12/22/2025K250959BioticsAIBioticsai, Inc.RadiologyIYN
12/22/2025K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiologyIYN
12/19/2025K252670AlzevitaTOPIA MEDTECH LIMITEDRadiologyQIH
12/19/2025K252284eMurmur Heart AICsd LabsCardiovascularDQD
12/19/2025K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseSiemens Healthcare GmbHRadiologyLNH
12/19/2025K252029AI-CVDHeartLung CorporationRadiologyQIH
12/18/2025K250914MediAI-BACrescom Co., Ltd.RadiologyQIH
12/18/2025K253516Assert-IQ (DM5100)Abbott MedicalCardiovascularMXD
12/18/2025K252235PVAD IQ SoftwareUltrasight , Ltd.RadiologyQIH
12/17/2025K251416UltraSight GuidanceUltrasight , Ltd.RadiologyQJU
12/17/2025K252922Neosoma Brain MetsNeosoma, Inc.RadiologyQIH
12/16/2025K251763IRISegIntuitive Surgical, Inc.RadiologyQIH
12/16/2025K252204prolaio eVO2peak Module (Version 1.0)Prolaio, Inc.CardiovascularPPW
12/12/2025K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.RadiologyLNH
12/11/2025K252482CogNet AI-MT+Medcognetics, Inc.RadiologyQFM
12/11/2025K253141DeepRhythmAIMedicalgorithmics S.A.CardiovascularDQK
12/10/2025K252497SANSA HSATHuxley MedicalAnesthesiologyMNR
12/09/2025K243449INFINITT DPSInfinitt Healthcare Co., Ltd.PathologyQKQ
12/08/2025K252294Fetal EchoScan (v1.2)BrightheartRadiologyPOK
12/08/2025K251936Ceribell Delirium Monitor SystemCeribell, Inc.NeurologyNCG
12/05/2025K251657Personalized Therapy Comfort Settings (PTCS)ResMed CorpAnesthesiologyBZD
12/05/2025K250780ARTAssistantManteia Technologies Co., Ltd.RadiologyQKB
12/05/2025K251514Overjet CBCT AssistOverjet, Inc.RadiologyQIH
12/05/2025K252504Gastric AlimetryAlimetry , Ltd.Gastroenterology-UrologyMYE
12/03/2025K251203AVIEW Lung Nodule CADCoreline Soft Co.,LtdRadiologyOEB
12/02/2025K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak MedicalRadiologyQIH
12/01/2025K251370Cartesion Prime (PCD-1000A/3) V10.21Canon Medical Systems CorporationRadiologyKPS
11/28/2025K252217CT VScore+Canon Medical Informatics, Inc.RadiologyJAK
11/26/2025K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.RadiologyOXO
11/25/2025K250694Scaida BrainCT-ICH (v1.0)Mlhealth 360RadiologyQAS
11/25/2025K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.P.A.RadiologyIYN
11/24/2025K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22Ge Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
11/24/2025K252366a2z-Unified-TriageA2z Radiology Ai, Inc.RadiologyQAS
11/21/2025K251293CardioVisionIcardio.AiCardiovascularQUO
11/21/2025K251506Nelli (Version 7.11)Neuro Event Labs OYNeurologyPOS
11/20/2025K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.RadiologyLNH
11/17/2025K252086DTX Studio AssistNobel Biocare C/O Medicim NVRadiologyMYN
11/17/2025K252330DeepRESPNox Medical EhfNeurologyOLZ
11/14/2025K250525Second Opinion® PanoramicPearl, Inc.RadiologyMYN
11/14/2025K251078AutoDensityEos ImagingRadiologyQIH
11/12/2025K252452PeekMed webPeek Health, S.A.RadiologyQIH
11/07/2025K250264SugarBug (1.x)Bench7, Inc.RadiologyMYN
11/07/2025K252041Fibresolve (with PCCP)Imvaria, Inc.RadiologyQWO
11/06/2025K253265BriefCase-TriageAidoc Medical , Ltd.RadiologyQAS
11/03/2025K2503303mensio WorkstationPie Medical Imaging BVRadiologyQIH
11/03/2025K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak MedicalRadiologyLLZ
10/31/2025K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems CorporationRadiologyIYN
10/30/2025K250337AiORTA - PlanViTAA Medical Solutions, Inc.RadiologyQIH
10/29/2025K251985LOGIQ E10Ge Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
10/29/2025K251963LOGIQ E10sGe Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
10/29/2025K250882SANSA HSATHuxley MedicalAnesthesiologyMNR
10/27/2025K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.RadiologyQIH
10/24/2025K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AGRadiologyQIH
10/23/2025K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.RadiologyQIH
10/22/2025K252298ANDI 2.0Imeka Solutions, Inc.RadiologyQIH
10/20/2025K252665brAIn™ Shoulder PositioningAvatar MedicalRadiologyQIH
10/17/2025K251673X9 Ultrasound SystemX9, Inc.RadiologySGH
10/17/2025K251355X1-FFRSpectrawave, Inc.RadiologyQHA
10/10/2025K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems CorporationRadiologyOWB
10/10/2025K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept BioroboticsGeneral and Plastic SurgeryPZP
10/09/2025K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCRadiologyIYN
10/07/2025K252214AIAS CephalonMetamorphosis GmbHRadiologyQIH
10/06/2025K252007BlineSlideDeep Breathe, Inc.RadiologyQIH
10/03/2025K250662Bunkerhill MACBunkerhill HealthRadiologyJAK
10/03/2025K252178MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.Gastroenterology-UrologyQNP
10/03/2025K251639xvision Spine systemAugmedics, Ltd.NeurologySBF
10/02/2025K250766LungQ 4Thirona BVRadiologyJAK
09/29/2025K250023SMART PCFDDisior LtdRadiologyQIH
09/29/2025K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.NeurologySBF
09/26/2025K252105Ligence HeartLigence, UABRadiologyQIH
09/25/2025K252371uMR 680Shanghai United Imaging Healthcare Co., Ltd.RadiologyLNH
09/25/2025K251527Brain WMHQuantib BVRadiologyQIH
09/23/2025K251483SwiftSight-BrainAIRS Medical Inc.RadiologyQIH
09/23/2025K251987Rapid Aortic MeasurementsiSchemaView, Inc.RadiologyQIH
09/19/2025K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.RadiologyKPR
09/19/2025K251002Videa Dental AIVideaHealth Inc.RadiologyMYN
09/19/2025K250649Bunkerhill ECG-EFBunkerHill HealthCardiovascularQYE
09/18/2025K250369Axial3D InsightAxial Medical Printing LimitedRadiologyQIH
09/17/2025K251386ECHELON SynergyFujifilm CorporationRadiologyLNH
09/17/2025K251221Assert-IQ  (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)AbbottCardiovascularMXD
09/15/2025K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.RadiologyQIH
09/12/2025K252586CADDIEOdin Medical LimitedGastroenterology-UrologyQNP
09/12/2025K251518Volta AF-Xplorer IIVolta MedicalCardiovascularDQK
09/12/2025K251368FETOLYDiagnolyRadiologyIYN
09/11/2025K251399SIGNA™ SprintGE Medical Systems, LLCRadiologyLNH
09/11/2025K250507Hypertension Notification Feature (HTNF)Apple Inc.CardiovascularSFR
09/11/2025K251316Mazor X System / Mazor X Stealth EditionMazor Robotics Ltd.NeurologyOLO
09/10/2025K244002AngioWaveNetAngiowave Imaging, Inc.RadiologyQIH
09/09/2025K251072Segmentron ViewerDGNCT, LLCRadiologyQIH
09/09/2025K251682MuscleView 2.0Springbok, Inc. (dba Springbok Analytics)RadiologyLNH
09/08/2025K251931BioTraceIO Vision  (V1.7)Techsomed Medical TechnologiesRadiologyQTZ
09/08/2025K251610qER-CTA (v1.0)Qure.ai TechnologiesRadiologyQAS
09/04/2025K251533Rapid Obstructive Hydrocephalus, Rapid OHiSchemaView Inc.RadiologyQAS
09/04/2025K250064Dose+ (1.0)Mvision AI OyRadiologyMUJ
09/04/2025K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte. Ltd.RadiologyQIH
09/03/2025K252539Tempus PixelArterys, Inc.RadiologyQIH
09/02/2025K251408OsteoSight™ Hip (v1)Naitive Technologies LtdRadiologySAO
09/02/2025K250753VELMENI for DENTISTS (V4D)Velmeni Inc.RadiologyMYN
08/29/2025K251106Sonosite LX and Sonosite PX Ultrasound SystemsFujifilm Sonosite IncRadiologyIYN
08/29/2025K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology Inc.PathologyPZM
08/29/2025K250290SurgiTwinTwinsightRadiologyLLZ
08/29/2025K243859PRAEVAorta®2NureaRadiologyQIH
08/28/2025K250788Definium Tempo SelectGE Hualun Medical Systems Co., LtdRadiologyKPR
08/27/2025K243687Vital SignsOxehealth LimitedCardiovascularQME
08/26/2025K251983Brainomix 360 Triage StrokeBrainomix LimitedRadiologyQAS
08/22/2025K252362GBrain MRIGalileo CDS, IncRadiologyQIH
08/22/2025K243685MammoScreen BDTherapixelRadiologyQIH
08/21/2025K251029Vista OS, Vista AI Scan, RTHawkVista AI, Inc.RadiologyLNH
08/20/2025K251590Methinks CTA StrokeMethinks Software S.L.RadiologyQAS
08/20/2025K251837Salix Coronary Plaque (V1.0.0)Artrya LimitedRadiologyQIH
08/20/2025K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.RadiologyIYN
08/15/2025K251747VEA Align; spineEOSEOS imagingRadiologyQIH
08/15/2025K250818NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S.AnesthesiologyQRG
08/15/2025K243851CHLOE BLASTFairtility Ltd.Obstetrics and GynecologyPBH
08/12/2025K250755DS Core DiagnosisDentsply Sirona Inc.RadiologyQIH
08/12/2025K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.CardiovascularDQD
08/11/2025K251873Saige-DxDeepHealth, Inc.RadiologyQDQ
08/07/2025K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)RadiologyQIH
08/06/2025K250569Cardiologs Holter PlatformPhilips France CommercialCardiovascularDPS
08/05/2025K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.RadiologyLNH
08/01/2025K250941Revolution VibeGE Medical Systems, LLCRadiologyJAK
07/31/2025K243341Genius AI Detection 2.0Hologic, Inc.RadiologyQDQ
07/31/2025K250738YSIO X.preeSiemens Medical SolutionsRadiologyKPR
07/31/2025DEN240068ArteraAI ProstateArtera Inc.PathologySFH
07/30/2025K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions ABRadiologyQIH
07/28/2025K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.CardiovascularQYE
07/25/2025K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary care Diagnostics,RadiologyIYN
07/24/2025K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
07/23/2025K243681Neuro Insight V1.0Olea Medical S.A.S.RadiologyLLZ
07/22/2025K250901Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiologyLNH
07/22/2025K250686GyriCalc (Version 1.0.0)NeuroSpectrum Insights Corp.RadiologyLLZ
07/18/2025K250902HeartFlow AnalysisHeartFlow, Inc.CardiovascularPJA
07/18/2025K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
07/17/2025K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.RadiologyLNH
07/17/2025K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd.RadiologyKPS
07/16/2025K243397uMR 680Shanghai United Imaging Healthcare Co., Ltd.RadiologyLNH
07/16/2025K251151Rapid CTA 360iSchemaViewRadiologyQAS
07/16/2025K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyQIH
07/15/2025K250119Tempus ECG-Low EFTempus AI, Inc.CardiovascularQYE
07/14/2025K251096PeekMed webPeek Health, S.A.RadiologyQIH
07/14/2025K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical SolutionsRadiologyOWB
07/10/2025K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
07/08/2025K251766TumorSight VizSimBioSys, Inc.RadiologyQIH
07/07/2025K243884TAVIPILOTCaranx MedicalRadiologyOWB
07/03/2025K243679MammoScreen® (4)TherapixelRadiologyQDQ
07/03/2025K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.RadiologyQIH
07/01/2025K250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging Inc.RadiologyPOK
07/01/2025K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill HealthRadiologyQIH
07/01/2025K250096Felix NeuroAI  SystemFasikl IncorporatedNeurologyQBC
06/30/2025K250484PIUR tUS insidePIUR Imaging GmbHRadiologyQIH
06/30/2025K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas CorporationRadiologyQIH
06/30/2025K250670EchoConfidence (USA)Mycardium AI LimitedRadiologyQIH
06/27/2025K250984Maestro System (REF100)Moon SurgicalGastroenterology-UrologyQZB
06/27/2025K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.HematologyJOY
06/24/2025K250268HyperSnap Surgical System (HSS)Hypervision SurgicalGastroenterology-UrologySFE
06/20/2025K250877TMINI Miniature Robotic SystemTHINK Surgical, Inc.NeurologyOLO
06/20/2025K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.AiCardiovascularSDJ
06/19/2025K250515EpiMonitorEmpatica  SrlNeurologyPOS
06/18/2025K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLCRadiologyIYN
06/18/2025K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote S.p.A.RadiologyIYN
06/18/2025K243672CardIQ SuiteGE Medical Systems SCSRadiologyJAK
06/17/2025K250440RT Elements  (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RTBrainlab AGRadiologyMUJ
06/16/2025K250436MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance , Ltd.RadiologyLNH
06/16/2025K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbHRadiologyLNH
06/16/2025K250685Methinks NCCT StrokeMethinks Software S.L.RadiologyQAS
06/15/2025K240795Withings ECG AppWithingsCardiovascularQDA
06/13/2025K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)Brainlab AGRadiologyQIH
06/12/2025K243234Second Opinion® CSPearl Inc.RadiologyMYN
06/12/2025K251153AuroraGE Medical Systems IsraelRadiologyKPS
06/10/2025K250354Viz Subdural+, Viz SUBDURAL PLUSViz.ai, Inc.RadiologyQIH
06/06/2025K251009Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc.RadiologyQIH
06/06/2025K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.R.L.CardiovascularMWI
06/05/2025K251456BrightHeart View ClassifierBrightHeartRadiologyQIH
06/05/2025K243667Sonic DLGE Medical Systems, LLCRadiologyLNH
06/04/2025K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemPhilips Medical Systems Nederland B.V.RadiologyLNH
06/04/2025K243810TraumaCad Neo (1.1)Brainlab Ltd.RadiologyQIH
06/04/2025K250749PhysCade SystemPhysCade, Inc.CardiovascularDQK
05/30/2025K243005AudaxCeph Cephalogram Analysis SoftwareAudax d.o.o.RadiologyQIH
05/30/2025K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.RadiologyLNH
05/30/2025K243863Opulus™ Lymphoma PrecisionRoche Molecular Systems, Inc.RadiologyQIH
05/30/2025DEN240047Allix5Clairity, Inc.RadiologySEZ
05/30/2025K251406BriefCase-TriageAidoc Medical, Ltd.RadiologyQAS
05/30/2025K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., LTD.HematologyPOV
05/29/2025K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary care DiagnosticsRadiologyIYN
05/28/2025K250367CoLumboXSmart Soft Healthcare ADRadiologyQIH
05/28/2025K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.RadiologyQKB
05/28/2025K243378Rapid MLSiSchemaview Inc.RadiologyQIH
05/27/2025K250932DeepRhythmAIMedicalgorithmics S.A.CardiovascularDQK
05/23/2025K243937Accuro 3SRivanna Medical, Inc.RadiologyIYO
05/23/2025K242594DEEPECHODeepEchoRadiologyIYN
05/23/2025K250005Clever OneEwoosoft Co., LtdRadiologyQIH
05/23/2025K243989Second Opinion® 3DPearl, Inc.RadiologyQIH
05/21/2025K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
05/21/2025K243762Synapse 3D Base Tools (V7.0)FUJIFILM CorporationRadiologyQIH
05/21/2025K243866InVision Precision Cardiac AmyloidInVision Medical Technology CorporationCardiovascularSDJ
05/21/2025K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.RadiologyLNH
05/21/2025K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.RadiologyLNH
05/20/2025K250370SCENARIA View Phase 5.0FUJIFILM CorporationRadiologyJAK
05/16/2025K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co.,Ltd.RadiologyJAK
05/16/2025K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote S.p.A.RadiologyIYN
05/16/2025K250086OTS HipOrtoma ABNeurologyOLO
05/16/2025K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.RadiologyOEB
05/14/2025K242437Smile Dx®Cube Click, Inc.RadiologyMYN
05/14/2025K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.RadiologyQIH
05/09/2025K243812Volta AF-XplorerVolta MedicalCardiovascularDQK
05/09/2025K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., LTD.HematologyPOV
05/09/2025K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLCRadiologyIYN
05/09/2025K251126SKOUT systemIterative HealthGastroenterology-UrologyQNP
05/09/2025K243230Second Opinion® BLEPearl Inc.RadiologyQIH
05/08/2025K250226Clarius Median Nerve AIClarius Mobile Health Corp.RadiologyQIH
05/07/2025K243684BrightHeart View ClassifierBrightHeartRadiologyQIH
05/05/2025K243893Second Opinion® PediatricPearl, Inc.RadiologyMYN
05/02/2025K251071Fetal EchoScan (v1.1)BrightHeartRadiologyPOK
05/02/2025K242583AT-Patch (ATP-C130/ATP-C70)ATsens Co.,Ltd.CardiovascularDSH
05/01/2025K250087Vscan AirGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
04/30/2025P230022Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin PreparatiElement Science, Inc.CardiovascularMVK
04/30/2025K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems CorporationRadiologyQIH
04/28/2025K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co.,Ltd.RadiologyOWB
04/24/2025K243239Lung AI (LAI001)Exo IncRadiologyMYN
04/23/2025K250831Annalise EnterpriseAnnalise-AIRadiologyQFM
04/21/2025K243651VersaViewerGE Medical Systems SCSRadiologyLLZ
04/17/2025K243878CLARUS (700)Carl Zeiss Meditec, Inc.OphthalmicQER
04/17/2025K242129VitalRhythmVitalConnect, Inc.CardiovascularDQK
04/16/2025K242500LARALABLARALAB GmbHRadiologyQIH
04/16/2025K243853Clarius Prostate AIClarius Mobile Health Corp.RadiologyQIH
04/15/2025K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta Ltd.RadiologyJAK
04/11/2025K250416GBrain MRIGalileo CDS, IncRadiologyQIH
04/11/2025K243558Canvas DxCognoa, Inc.NeurologyQPF
04/11/2025K242748OncospaceOncospace, Inc.RadiologyMUJ
04/11/2025K242600Second Opinion Periapical Radiolucency ContoursPearl Inc.RadiologyMYN
04/10/2025K243145syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc.RadiologyQAS
04/10/2025K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
04/10/2025K250754cmAngio® (V1.6)CureMetrix, Inc.RadiologyQIH
04/09/2025K243743autoSCORE (V 2.0.0)Holberg EEG ASNeurologyOMB
04/08/2025K242295BunkerHill BMDBunkerHill HealthRadiologyKGI
04/07/2025K243567Tyto Insights for Rhonchi DetectionTyto Care , Ltd.AnesthesiologyPHZ
04/04/2025K242807HeartFocus (V.1.1.1)DeskiRadiologyQJU
04/04/2025K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3RaySearch Laboratories AB (PUBL)RadiologyMUJ
04/04/2025K243769QFR (3.0)QFR Solutions bvRadiologyQHA
04/04/2025K241982DeepFoqus (DeepFoqus-Accelerate)Foqus Technologies Inc.RadiologyQIH
04/03/2025K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbHRadiologyQIH
04/02/2025K241984Hi-D Imaging 4TAVRHi-D Imaging AGRadiologyQIH
04/01/2025K242925MR Contour DLGE HealthCareRadiologyQKB
03/31/2025K242166TribusConnectTribusMed Beheer BVRadiologyQIH
03/27/2025K242745AI-Rad Companion Organs RTSiemens Healthcare GmbHRadiologyQKB
03/27/2025K243038Salix CentralArtrya LimitedRadiologyQIH
03/27/2025K242919V5med Lung AIV5med Inc.RadiologyOEB
03/26/2025K243891EarliPoint SystemEarliTec DiagnosticsNeurologyQPF
03/26/2025K243831Rayvolve LNAZmedRadiologyMYN
03/21/2025K243808Rayvolve PTX-PEAZmedRadiologyQFM
03/21/2025K250186GoLIF! Lumbar Interbody Fusion SystemGetSet Surgical, SAOrthopedicMAX
03/20/2025K241961Vent Creativity Knee v1.0 (Hermes)Vent CreativityRadiologyQIH
03/20/2025K243292brAIn™ Shoulder PositioningAvatar MedicalRadiologyLLZ
03/19/2025K243689AVIEWCoreline Soft Co., Ltd.RadiologyQIH
03/19/2025K250042PeekMed webPeek Health, S.A.RadiologyQIH
03/18/2025K242683QP-Prostate® CADQuibim S.L.RadiologyQDQ
03/17/2025K243862LVivo Software ApplicationDiA Imaging Analysis Ltd.RadiologyQIH
03/17/2025K250379SIGNA Prime EliteGE Medical Systems, LLCRadiologyLNH
03/14/2025K241960DeepRESPNox Medical ehfNeurologyOLZ
03/14/2025K242323Maestro System (REF100)Moon SurgicalGastroenterology-UrologyQZB
03/13/2025K250255xvision Spine systemAugmedics Ltd.NeurologySBF
03/11/2025K241725Better Diagnostics Caries Assist (BDCA) Version 1.0Better Diagnostics AI CorpRadiologyMYN
03/07/2025K242338Cleerly LABS (v2.0)Cleerly, Inc.RadiologyQIH
03/06/2025K243331LVivo SeamlessDiA Imaging Analysis Ltd.RadiologyQIH
03/05/2025K241770Prostate MR AI (VA10A)Siemens Healthcare GmbHRadiologyQDQ
03/04/2025K243933Ceevra Reveal 3+Ceevra, Inc.RadiologyQIH
03/03/2025K243235LVivo Software ApplicationDiA Imaging Analysis Ltd.RadiologyQIH
03/03/2025K243611JLK-SDHJLK, Inc.RadiologyQAS
02/28/2025K241922MyomicsPhantomics Inc.RadiologyQIH
02/28/2025K242798AirmodHeroic Faith International Ltd.AnesthesiologyBZQ
02/27/2025K241620ChestView USGleamer SASRadiologyMYN
02/26/2025K241546aiCockpit AI ViewerFovia, Inc.RadiologyLLZ
02/26/2025K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics Ltd.RadiologyQIH
02/25/2025K242967Loss of Pulse DetectionFitbitCardiovascularSDY
02/25/2025K2434463DXRGE Medical Systems SCSRadiologyOWB
02/25/2025K242822ART-Plan+ (v.3.0.0)Therapanacea SASRadiologyMUJ
02/24/2025K242994OncoStudio (OS-01)OncoSoft. Co., Ltd.RadiologyQKB
02/21/2025K242838QuickRadAikenist Technologies Pvt LtdRadiologyLLZ
02/21/2025K242607ScanDiags Ortho L-Spine MR-QScanDiags AGRadiologyQIH
02/21/2025K243614Sonio SuspectSonioRadiologyPOK
02/20/2025K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)Ever Fortune.AI, Co., Ltd.RadiologyQAS
02/20/2025K242447Falcon HSTCompumedics LimitedNeurologyOLV
02/20/2025K242240CaRi-PlaqueCaristo Diagnostics Ltd.RadiologyLLZ
02/14/2025K250248BriefCase-TriageAidoc Medical, Ltd.RadiologyQAS
02/14/2025K243294Brainomix 360 e-ASPECTSBrainomix LimitedRadiologyPOK
02/14/2025K243696AVIEW CACCoreline Soft Co., Ltd.RadiologyQIH
02/12/2025K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
02/12/2025K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.RadiologyJAK
02/12/2025K243250SubtleHD (1.x)Subtle Medical, Inc.RadiologyQIH
02/11/2025K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
02/11/2025K243620Vivid iqGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
02/10/2025K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound LLCRadiologyQIH
02/06/2025K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
02/05/2025K241593BoneMetrics (US)Gleamer SASRadiologyQIH
02/03/2025K250035Contour ProtégéAI+MIM Software Inc.RadiologyQKB
02/03/2025K243268TipTraQ (TTQ001)PranaQ Pte. Ltd.AnesthesiologyMNR
01/30/2025K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.OrthopedicKWS
01/29/2025K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.General and Plastic SurgeryGEH
01/28/2025K244027SANSA HSATHuxley MedicalAnesthesiologyMNR
01/27/2025K243229Bunkerhill AVCBunkerHill HealthRadiologyJAK
01/24/2025K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.NeurologyHAW
01/24/2025K244023MAGENTIQ-COLO (ME-APDS)Magentiq Eye LTDGastroenterology-UrologyQNP
01/24/2025K241232Galen™ Second Read™Ibex Medical Analytics Ltd.PathologyQPN
01/23/2025K243158TeraRecon Aorta.CT (1.1.0)TeraRecon, Inc.RadiologyQIH
01/22/2025K243350Rapid Neuro3DiSchemaView, Inc.RadiologyQIH
01/21/2025K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty LtdOrthopedicQHE
01/17/2025K242825Prenuvo Body CompositionPrenuvoRadiologyLNH
01/17/2025K242171TechCare TraumaMilvueRadiologyQBS
01/17/2025K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.RadiologyIYN
01/16/2025K242522Second Opinion CCPearl Inc.RadiologyMYN
01/15/2025K243065Cardiac GuidanceCaption Health, Inc.RadiologyQJU
01/14/2025K241166uCT 550Shanghai United Imaging Healthcare Co., Ltd.RadiologyJAK
01/13/2025K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta Ltd.RadiologyJAK
01/13/2025K243950ARVIS® ShoulderKico Knee Innovation Company Pty LtdNeurologySBF
01/10/2025K241009PeriCALM Patterns 3.0PeriGen, Inc.Obstetrics and GynecologyHGM
01/10/2025K241891ScreenDxImvaria, IncRadiologyQWO
01/10/2025K241676TriVerityInflammatix, Inc.MicrobiologyPRE
01/07/2025K243335Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiologyLNH
01/07/2025K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.RadiologyJAK
01/06/2025K242488Soteria E-ViewOmega Medical Imaging, LLCRadiologyJAA
01/06/2025K243481TMINI Miniature Robotic SystemTHINK Surgical, Inc.NeurologyOLO
01/06/2025K242123Brainomix 360 e-CTABrainomix LimitedRadiologyLLZ
01/03/2025K241350Clarify DLGE Medical Systems Israel, Functional ImagingRadiologyLLZ
01/03/2025K243363JLK-ICHJLK, Inc.RadiologyQAS
01/02/2025K241696Ortho AIOrtho AI LLCRadiologyQIH
01/02/2025K242334Ezra FlashEzra AI, Inc.RadiologyQIH
12/27/2024K242480FLASH EVD System (10-0002)7D Surgical ULCNeurologyHAW
12/23/2024K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems CorporationRadiologyJAK
12/20/2024K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care DiagnosticsRadiologyIYN
12/20/2024K242362Lightning ViewerNexsys Electronics Inc. dba MedwebRadiologyLLZ
12/19/2024K243705Saige-Density (2.5.0)DeepHealth, IncRadiologyQIH
12/19/2024K242270OrthoNext Platform SystemOrthofix SrlRadiologyQIH
12/19/2024K242467IQ-UIPImbio, Inc.RadiologyQWO
12/19/2024K243688Saige-Dx (3.1.0)DeepHealth, Inc.RadiologyQDQ
12/16/2024K240793MSKaiMSKaiRadiologyQIH
12/12/2024K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
12/12/2024K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co.,Ltd.RadiologyKPS
12/11/2024K243548BriefCase-TriageAidoc Medical, Ltd.RadiologyQFM
12/10/2024K242461IRISegIntuitive Surgical Inc.RadiologyQIH
12/10/2024K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
12/09/2024K242729AutoContour (Model RADAC V4)Radformation, Inc.RadiologyQKB
12/06/2024K241543DrAid™ for Liver SegmentationVinBrain Joint Stock CompanyRadiologyQIH
12/06/2024K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)Ever Fortune.AI, Co., Ltd.RadiologyQAS
12/06/2024K240680CDM InsightsOxford Brain Diagnostics LtdRadiologyQIH
12/06/2024K240926PeekMed webPeek Health, S.A.RadiologyLLZ
12/04/2024K241197DeepRhythmAIMedicalgorithmics S.A.CardiovascularDQK
12/03/2024K242188ClearRead CT CACRiverain Technologies, Inc.RadiologyJAK
11/27/2024K240645Sonix HealthOntact Health Co., LtdRadiologyQIH
11/27/2024K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
11/26/2024K241390NeuroMatchLVIS CorporationNeurologyOMB
11/25/2024K241831Transpara (2.1.0)ScreenPoint Medical B.V.RadiologyQDQ
11/22/2024K242203BriefCase-QuantificationAidoc Medical, Ltd.RadiologyQIH
11/22/2024K242094Dreem 3SBeacon Biosignals, Inc.NeurologyOLZ
11/20/2024K242359Strain AI (SAI001)Exo IncRadiologyQIH
11/19/2024K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.RadiologyIYN
11/18/2024K241633Informed Vital Core Application (IVC App)Mindset Medical, Inc.CardiovascularQME
11/18/2024K241747Saige-DxDeepHealth, IncRadiologyQDQ
11/15/2024K242130Koios DSKoios Medical, Inc.RadiologyPOK
11/15/2024K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno Inc.RadiologyQFM
11/15/2024K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound LLCRadiologyIYN
11/15/2024K2420621CMR ProMycardium AI LimitedRadiologyLLZ
11/15/2024K240860EchoGo Amyloidosis (1.0)Ultromics LimitedCardiovascularSDJ
11/14/2024K242342Fetal EchoScanBrightHeartRadiologyPOK
11/08/2024K240417ProFound Detection (V4.0)iCAD, Inc.RadiologyQDQ
11/07/2024K241719NeuroICHNeurocareai Inc.RadiologyQAS
11/07/2024K240712icobrain ariaicometrix NVRadiologyQBS
11/05/2024K241312TeraRecon Cardiac.Chambers.MR (1.0.0)TeraRecon,Inc.RadiologyQIH
10/30/2024K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic Inc.RadiologyQIH
10/25/2024K243189TumorSight VizSimBioSys, Inc.RadiologyQIH
10/25/2024K242215Neurophet AQUA (V3.1)Neurophet, Inc.RadiologyQIH
10/22/2024K243209nordicMEDiVANordicNeurolab ASRadiologyLLZ
10/18/2024K241490Contour+ (MVision AI Segmentation)MVision AI OyRadiologyQKB
10/18/2024K242837BriefCase-TriageAidoc Medical, Ltd.RadiologyQAS
10/17/2024K241242SIGNA MAGNUSGE Medical Systems, LLCRadiologyLNH
10/17/2024K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, IncNeurologyOMB
10/16/2024K241481xvision Spine SystemAugmedics Ltd.NeurologySBF
10/15/2024K242781cvi42 Software ApplicationCircle Cardiovascular Imaging Inc.RadiologyQIH
10/11/2024K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
10/10/2024K241430EchoMeasureiCardio.aiRadiologyQIH
10/09/2024K241837Limbus ContourLimbus AI Inc.RadiologyQKB
10/07/2024K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
10/07/2024K241029SpineUs™ SystemVerdure ImagingRadiologyIYO
10/04/2024K242652Lunit INSIGHT DBT v1.1Lunit Inc.RadiologyQDQ
10/04/2024K241245EchoSolv ASEcho IQ LtdRadiologyPOK
10/04/2024K240553LVivo Software ApplicationDiA Imaging Analysis Ltd.RadiologyQIH
10/02/2024K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
10/02/2024K241561MammoScreen BDTherapixelRadiologyQIH
10/01/2024K240943LungVisionBodyVision Medical Ltd.RadiologyQIH
10/01/2024K241331MuscleViewSpringbok, Inc.RadiologyLNH
09/27/2024K240993encevis (2.1)AIT Austrian Institute of Technology GmbHNeurologyOMB
09/27/2024K240369CAC (gated) AlgorithmBunkerHill HealthRadiologyJAK
09/27/2024K241480JBS-LVOJLK, Inc.RadiologyQAS
09/24/2024K242292uAI Easy Triage ICHShanghai United Imaging Intelligence Co., Ltd.RadiologyQAS
09/23/2024K240013EchoGo Heart Failure (2.0)Ultromics LimitedCardiovascularQUO
09/23/2024P140011/S008MAMMOMAT B.brilliant with Tomosynthesis OptionSIEMENS MEDICAL SOLUTIONS USA, INC.RadiologyOTE
09/20/2024K240036PIUR tUS InfinityPIUR Imaging GmbHRadiologyQIH
09/13/2024K240929Sleep Apnea Notification Feature (SANF)Apple Inc.AnesthesiologyQZW
09/12/2024K241280Constellation (CON-001)Q Bio, Inc.RadiologyQIH
09/12/2024K240942CINA-CSpineAvicenna.AIRadiologyQAS
09/12/2024K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)Canon Medical Systems CorporationRadiologyIYN
09/11/2024K241380FETOLY-HEARTDiagnolyRadiologyIYN
09/10/2024K240094LumiNE US; LumiAugmedit B.V.RadiologyQIH
09/09/2024K240791ADAS 3DAdas3D Medical S.LRadiologyQIH
09/09/2024K241681Overjet Image Enhancement AssistOverjet IncRadiologyQIH
09/09/2024K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte. Ltd.RadiologyQDQ
09/06/2024K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.RadiologyQIH
09/05/2024K233998TRAQinform IQAIQ Global, Inc.RadiologyLLZ
09/04/2024K233977VelacurSonic IncytesRadiologyIYO
08/30/2024K240003Velmeni for Dentists (V4D)Velmeni Inc.RadiologyMYN
08/30/2024K241847Imbio PHA (4.0.0)Imbio, IncRadiologyQIH
08/30/2024K241585uMI PanoramaShanghai United Imaging Healthcare Co.,Ltd.RadiologyKPS
08/30/2024K242300MI View&GOSiemens Medical Solutions USA, Inc.RadiologyQIH
08/30/2024K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.RadiologyQIH
08/29/2024K233826KosmosEchoNous, Inc.RadiologyIYN
08/27/2024K241684Overjet Charting AssistOverjet, IncRadiologyQIH
08/22/2024K241098NeuroQuantCorTechs Labs, Inc.RadiologyQIH
08/21/2024K240290AiMIFY (1.x)Subtle Medical, Inc.RadiologyLLZ
08/20/2024K241496Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiologyLNH
08/20/2024K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept BioRoboticsGeneral and Plastic SurgeryPZP
08/19/2024K241440HealthCCSngNano-X AI Ltd.RadiologyJAK
08/16/2024K240740qCT LN QuantQure.ai TechnologiesRadiologyQIH
08/16/2024K233755HeartKey® RhythmB-Secur LimitedCardiovascularDQK
08/15/2024K241596uMI PanvivoShanghai United Imaging Healthcare Co., Ltd.RadiologyKPS
08/15/2024K241211CoLumboSmart Soft HealthcareRadiologyQIH
08/13/2024K241429ECHELON Synergy MRI SystemFUJIFILM Healthcare CorporationRadiologyLNH
08/12/2024K242054OptimMRI (v2)Rebrain, SASRadiologyQIH
08/08/2024K233822i2ContourMRIMath LLCRadiologyQIH
08/08/2024K241665Omni LegendGE Medical Systems Israel, Functional ImagingRadiologyKPS
08/05/2024K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty LtdOrthopedicQHE
08/05/2024K240953AI Platform 2.0 (AIP002)Exo ImagingRadiologyQIH
08/02/2024K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLCCardiovascularQMS
08/01/2024K234141AISAP Cardio V1.0AisapRadiologyPOK
08/01/2024K233731CardIQ SuiteGE Medical Systems SCSRadiologyJAK
08/01/2024K240301MammoScreen® (3)TherapixelRadiologyQDQ
07/25/2024K241887GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)Cosmo Artificial Intelligence - AI LtdGastroenterology-UrologyQNP
07/24/2024K240044CADDIEOdin Medical LimitedGastroenterology-UrologyQNP
07/22/2024K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE  Diagnostic Ultrasound SystemSiemens Medical Solutions, USA, Inc.RadiologyIYN
07/17/2024K240845RayvolveAZmed SASRadiologyQBS
07/17/2024K241121MICSI-RMTMicrostructure Imaging, Inc.RadiologyLLZ
07/16/2024K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.RadiologyLNH
07/15/2024K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley MedicalAnesthesiologyMNR
07/12/2024K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak MedicalRadiologyQIH
07/12/2024K233457RUSHutom Inc.RadiologyQIH
07/12/2024K241727BriefCase-TriageAidoc Medical, Ltd.RadiologyQAS
07/11/2024K241329SubtleSYNTH (1.x)Subtle Medical, Inc.RadiologyQIH
07/03/2024K241508SKOUT® systemIterative Scopes, Inc.Gastroenterology-UrologyQNP
07/02/2024K240736SMART Bun-Yo-Matic X-RayDisior LtdRadiologyQIH
07/02/2024K240555Tyto Insights for Crackles DetectionTyto Care Ltd.AnesthesiologyPHZ
07/01/2024K240353Hyper Insight - ICHSK Inc.RadiologyQAS
06/25/2024K240582VEA Align; spineEOSEOS imagingRadiologyQIH
06/21/2024K233253eCARTv5 Clinical Deterioration Suite (“eCART”)AgileMD, Inc.CardiovascularQNL
06/21/2024K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
06/21/2024K240465O-arm O2 Imaging SystemMedtronic Navigation, IncRadiologyOWB
06/21/2024K233196Medihub ProstateJLK Inc.RadiologyQIH
06/21/2024K233549Tempus ECG-AFTempus AI, Inc.CardiovascularSBQ
06/20/2024K240642SMART Bun-Yo-Matic CTDisior LtdRadiologyQIH
06/14/2024K241083SIS SystemSurgical Information Sciences, Inc.RadiologyQIH
06/14/2024K233955Clarius OB AIClarius Mobile Health Corp.RadiologyIYN
06/13/2024K233662Radiography 7300 CPhilips Medical Systems DMC GmbHRadiologyKPR
06/13/2024K233925Relu CreatorRelu BVRadiologyQIH
06/12/2024K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
06/07/2024K232035ImpalaAliveCor, Inc.CardiovascularDPS
06/07/2024K231010CorvairAliveCor, Inc.CardiovascularMHX
06/07/2024K241038Cardiac CT Function Software ApplicationCircle Cardiovascular ImagingRadiologyQIH
06/07/2024K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.AI Co., Ltd.RadiologyQIH
05/31/2024K240612CINA-VCFAvicenna.AIRadiologyQFM
05/24/2024K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.RadiologyOUO
05/24/2024K240769LVivo IQSDiA Imaging Analysis Ltd.RadiologyQIH
05/23/2024K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbHRadiologyLLZ
05/23/2024K233108VinDr-MammoVinBigData Joint Stock CompanyRadiologyQFM
05/21/2024K233543YSIO X.preeSiemens Medical SolutionsRadiologyKPR
05/17/2024DEN230035DentalMonitoringDental Monitoring SASDentalSBC
05/17/2024K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.RadiologyQIH
05/16/2024K233625RAYDENT SWRAY Co., Ltd.DentalPNN
05/15/2024K233247Heuron ICHHeuron Co., Ltd.RadiologyQAS
05/15/2024K241112BriefCase-QuantificationAidoc Medical, Ltd.RadiologyQIH
05/15/2024DEN230043Notal Vision Home Optical Coherence Tomography (OCT) SystemNotal Vision IncOphthalmicSAX
05/10/2024K232410SmartChestMilvueRadiologyQFM
05/07/2024K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.CardiovascularMWJ
05/07/2024K232928DeepContour (V1.0)Wisdom Technologies., Inc.RadiologyQKB
05/03/2024K233687ECHELON Synergy V10.0Fujifilm Healthcare Americas CorporationRadiologyLNH
05/03/2024K232416AUTION EYE AI-4510 Urine Particle Analysis SystemArkray Inc.HematologyLKM
05/03/2024K232491CT 5300Philips Healthcare (Suzhou) Co., Ltd.RadiologyJAK
04/30/2024K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems Inc.RadiologyIYE
04/29/2024K240062ARVIS® ShoulderInsight Medical Systems, Inc.NeurologyOLO
04/26/2024K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.RadiologyMUJ
04/26/2024K240406Sonio DetectSonioRadiologyIYN
04/26/2024K233673uMR JupiterShanghai United Imaging Healthcare Co., LtdRadiologyLNH
04/25/2024K232331InVision Precision LVEF (LVEF)InVision Medical Technology CorporationRadiologyQIH
04/24/2024K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLCRadiologyIYN
04/23/2024K240058AEYE-DSAEYE Health Inc.OphthalmicPIB
04/22/2024K234068ART-Plan (v.2.2.0)Therapanacea SASRadiologyMUJ
04/22/2024K233582RapidiSchema View Inc.RadiologyLLZ
04/19/2024K240781SKOUT® systemIterative Scopes, Inc.Gastroenterology-UrologyQNP
04/17/2024K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.RadiologyQIH
04/15/2024K240773VisAble.IOTechsomedRadiologyQTZ
04/12/2024K240238Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiologyLNH
04/11/2024K233698True Enhance DLGE Healthcare Japan CorporationRadiologyJAK
04/10/2024K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.RadiologyLNH
04/09/2024DEN230023Rho16 Bit IncRadiologySAO
04/08/2024K240291EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEMEver Fortune.AI, Co., Ltd.RadiologyQAS
04/05/2024K233666CorVista System with PH Add-OnAnalytics for Life, Inc.CardiovascularSAT
04/05/2024K233249APPRAISE-HRIThe Surgeon General, Department of the Army (TSG-DA)CardiovascularSAR
04/04/2024K240172Preview ShoulderGenesis Software InnovationsRadiologyQIH
04/03/2024K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.RadiologyQKB
04/03/2024K233618Oxevision Sleep DeviceOxehealth LimitedNeurologyLEL
04/02/2024DEN230036Sepsis ImmunoScorePrenosis, Inc.General HospitalSAK
04/02/2024K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems CorporationRadiologyJAK
04/01/2024K233676Us2.v2Eko.ai Pte. Ltd d/b/a Us2.aiRadiologyQIH
03/29/2024K233211AVIEW CACCoreline Soft Co., Ltd.RadiologyQIH
03/28/2024K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.RadiologyJAK
03/28/2024K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.CardiovascularQYE
03/26/2024K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.RadiologyJAK
03/22/2024K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc.RadiologyLNH
03/22/2024K232431syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc.RadiologyQAS
03/22/2024K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.RadiologyLNH
03/21/2024K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbHRadiologyJAK
03/20/2024K234047Automatic RegistrationBrainlab AGNeurologyOLO
03/15/2024K233342CINA-ASPECTSAvicenna.AIRadiologyPOK
03/13/2024K233968CINA-iPEAvicenna.AIRadiologyQAS
03/11/2024K232140OTS HipOrtoma ABNeurologyOLO
03/08/2024K233438SleepStageMLBeacon Biosignals, Inc.NeurologyOLZ
03/07/2024K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary care Diagnostics,RadiologyIYN
03/06/2024K231677EdgeFlow UH10Edgecare Inc.RadiologyIYO
03/04/2024K233738Overjet Caries Assist-PediatricOverjet, IncRadiologyMYN
03/01/2024K233030BoneMRIMRIguidance B.VRadiologyQIH
03/01/2024K231690iCAS-LVHighRAD Ltd.RadiologyQIH
02/29/2024K232765MAGNETOM Cima.X FitSiemens Medical Solutions USA, Inc.RadiologyLNH
02/29/2024K231683inHEART ModelsinHEART, SASRadiologyQIH
02/28/2024K232613CT CardiomegalyInnolitics, LLCRadiologyQIH
02/23/2024K233590Overjet Charting AssistOverjet, IncRadiologyQIH
02/22/2024K233749Revolution Ascend SlidingGE Hangwei Medical Systems Co., Ltd.RadiologyJAK
02/21/2024K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLCDentalQRY
02/15/2024K232915EpiMonitorEmpatica SrlNeurologyPOS
02/13/2024K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
02/13/2024K231855QOCA® image Smart RT Contouring SystemQuanta Computer Inc.RadiologyQKB
02/09/2024K231355AuroraEnsoDataAnesthesiologyMNR
02/08/2024K233080HealthFLDNano-X AI Ltd.RadiologyJAK
02/06/2024DEN230041Sleep Apnea FeatureSamsung Electronics Co., LtdAnesthesiologyQZW
02/05/2024K232363Viz HDS, Viz Volume Plus, Viz ICH+Viz.ai, Inc.RadiologyQIH
01/31/2024DEN210035“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”Hologic Inc.PathologyQYV
01/31/2024K231396CEPHX- Cephalometric Analysis SoftwareOrca Dental AI LTDRadiologyLLZ
01/24/2024K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems CorporationRadiologyIYN
01/19/2024K233728SIGNA ChampionGE Healthcare (Tianjin) Company LimitedRadiologyLNH
01/19/2024K232156Rapid ASPECTS (v3)iSchemaView, Inc.RadiologyPOK
01/18/2024K232698NemoScanSoftware Nemotec S.L.RadiologyQIH
01/17/2024K231871Radify TriageEnvisionit DeepAI LtdRadiologyQFM
01/16/2024K233512Rapid (6.0)iSchemaView, Inc.RadiologyQIH
01/13/2024K233216CLEWICU SystemClew Medical Ltd.CardiovascularQNL
01/12/2024K233677Biograph VK10Siemens Medical Solutions USA, Inc.RadiologyKPS
01/12/2024K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)Cosmo Artificial Intelligence - AI LtdGastroenterology-UrologyQNP
01/12/2024DEN230008DermaSensorDermaSensor Inc.General and Plastic SurgeryQZS
01/12/2024DEN220040FibresolveImvaria, IncRadiologyQWO
01/11/2024DEN220066BrainSeeDarmiyan, Inc.NeurologyQWT
01/11/2024K232250SurgiCount+ SystemStryker InstrumentsGeneral HospitalPBZ
01/08/2024K231324DASI Dimensions (V1.0)DASI SimulationsRadiologyQIH
01/08/2024K232412LungQ v3.0.0Thirona BVRadiologyJAK
01/07/2024K231068autoSCOREHolberg EEG ASNeurologyOMB
01/05/2024K231917VEA AlignEOS imagingRadiologyQIH
01/04/2024K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.RadiologyIYN
01/03/2024K231779REMI AI Discrete Detection ModuleEpitel, Inc.NeurologyOMB
12/26/2023K231130TumorSight VizSimBioSys, Inc.RadiologyQIH
12/22/2023K232535MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc.RadiologyLNH
12/22/2023K232479ART-PlanTheraPanaceaRadiologyMUJ
12/22/2023K231805qXR-LNQure.ai TechnologiesRadiologyMYN
12/21/2023K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison CO., LTD.RadiologyIYN
12/20/2023K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.RadiologyLLZ
12/20/2023K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.OrthopedicOOG
12/18/2023K231587MAGNETOM Cima.XSiemens Medical Solutions USA, Inc.RadiologyLNH
12/18/2023K231929iQ-solutionsSydney Neuroimaging Analysis Centre Pty LtdRadiologyQIH
12/15/2023K230751EW10-EC02 Endoscopy Support ProgramFUJIFILM CorporationGastroenterology-UrologyQNP
12/15/2023K232384Videa Dental AssistVideaHealth, Inc.RadiologyMYN
12/14/2023K231570StrokeViewer PerfusionNICo-Lab B.V.RadiologyLLZ
12/13/2023K232231QP-Brain®Quibim S.L.RadiologyQIH
12/13/2023K232237Tyto Insights for Wheeze DetectionTyto Care Ltd.AnesthesiologyPHZ
12/12/2023DEN230027NaviCam ProScan
  Ankon Technologies co., ltd		Gastroenterology-UrologyQZF
12/11/2023K232096Transpara Density 1.0.0Screenpoint Medical B.V.RadiologyQIH
12/08/2023K231898DTX Studio Clinic (4.0)Nobel Biocare ABRadiologyLLZ
12/08/2023K223757BonelogicDisior LtdRadiologyLLZ
12/07/2023K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary care Diagnostics,RadiologyIYN
12/07/2023K232661Myocardial Strain Software ApplicationCircle Cardiovascular ImagingRadiologyLLZ
12/06/2023K233334Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems CorporationRadiologyJAK
12/06/2023K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.CardiovascularMXD
12/05/2023K232440Adravision PerioAdra CorporationRadiologyQIH
12/05/2023K233568Ceevra Reveal 3+Ceevra, Inc.RadiologyQIH
12/01/2023K232856Syngo Carbon ClinicalsSiemens Healthcare GmbHRadiologyQIH
11/30/2023K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
11/29/2023K2301796440 MyLabX90Esaote S.p.A.RadiologyIYN
11/28/2023K231631BriefCase-QuantificationAidoc Medical, Ltd.RadiologyJAK
11/28/2023K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.RadiologyQIH
11/27/2023K233243ClearPoint System (Software Version 2.2)ClearPoint Neuro Inc.NeurologyHAW
11/21/2023K232496Brainomix 360 Triage StrokeBrainomix LimitedRadiologyQAS
11/17/2023K232501AI Platform (AIP001)Exo IncRadiologyQIH
11/15/2023K232841Axial3D InsightAxial Medical Printing LimitedRadiologyQIH
11/14/2023K232494MAGNETOM Avanto fit; MAGNETOM Skyra fitSiemens Medical Solutions USA, Inc.RadiologyLNH
11/13/2023K232083BriefCase-QuantificationAidoc Medical, Ltd.RadiologyQIH
11/13/2023K232257Clarius Bladder AIClarius Mobile Health Corp.RadiologyQIH
11/09/2023K223754BraveCXBering LtdRadiologyQFM
11/09/2023K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.RadiologyLNH
11/08/2023K230534BriefCase-QuantificationAidoc Medical, Ltd.RadiologyQIH
11/08/2023K231765Contour ProtégéAIMIM Software Inc.RadiologyQKB
11/07/2023K231966LOGIQ E10GE Medical Systems Ultrasound and Primary care Diagnostics,RadiologyIYN
11/07/2023K231989LOGIQ E10s, LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostic,RadiologyIYN
11/06/2023K231470Lunit INSIGHT DBTLunit Inc.RadiologyQDQ
11/03/2023K231955aprevo® Digital SegmentationCarlsmed, Inc.RadiologyQIH
10/30/2023K232751BriefCase-TriageAidoc Medical, Ltd.RadiologyQAS
10/30/2023K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics,RadiologyIYN
10/30/2023K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.RadiologyIYN
10/27/2023K232045MeVis Liver SuiteMeVis Medical Solutions AGRadiologyJAK
10/27/2023K230854SwiftMRAIRS Medical Inc.RadiologyLLZ
10/26/2023K232500Lumify Diagnostic Ultrasound SystemPhilips UltrasoundRadiologyIYN
10/25/2023K230842SignalHF (IM008)Implicity Inc.CardiovascularQNL
10/25/2023K232436Rapid SDHiSchemaView, Inc.RadiologyQAS
10/23/2023K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.RadiologyQIH
10/23/2023K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc.RadiologyLNH
10/23/2023K231764Ultrasound System 1300BK Medical ApsRadiologyIYN
10/20/2023K230209Sonix HealthOntact Health Co., Ltd.RadiologyQIH
10/13/2023K231642Veuron-Brain-pAb3Heuron Co., Ltd.RadiologyLLZ
10/13/2023K230370SpotLight/SpotLight Duo (with DLIR option)Arineta Ltd.RadiologyJAK
10/11/2023K230220NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.RadiologyJAK
10/06/2023K230144Denti.AI DetectDenti.AI Technology, Inc.RadiologyMYN
10/06/2023K223905Vivio® LVEDP SystemAvicena, LLCCardiovascularQUO
10/06/2023K232787ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound LimitedAnesthesiologyQRG
10/06/2023K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.RadiologyLNH
10/05/2023K232367cmAngio® V1.0CureMetrix, Inc.RadiologyQIH
10/05/2023K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.RadiologyIYN
10/05/2023K231001DeepTek CXR Analyzer v1.0DeepTek Medical Imaging Pvt LtdRadiologyMYN
10/04/2023K232023Momentum SpineMomentum Health Inc.RadiologyLDK
10/04/2023K231025EFAI NeuroSuite CT ICH Assessment SystemEver Fortune.AI Co., Ltd.RadiologyQAS
10/04/2023K231398VUNO Med-DeepBrainVUNO Inc.RadiologyQIH
10/03/2023K232712uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.RadiologyKPS
10/03/2023K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
10/03/2023K230085Lung-CADImagen Technologies, IncRadiologyMYN
09/29/2023K230045HipCheckStryker Corp.RadiologyQIH
09/28/2023K231837Brainomix 360 Triage LVOBrainomix LimitedRadiologyQAS
09/28/2023K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.CardiovascularQYE
09/27/2023K232616Volta AF-XplorerVolta MedicalCardiovascularDQK
09/26/2023K230252OFIX MIS AppOrthofix US LLCRadiologyLLZ
09/25/2023K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.AI Co., Ltd.RadiologyQKB
09/22/2023K231767Annalise Enterprise CTB Triage TraumaAnnalise-AI Pty LtdRadiologyQAS
09/22/2023K231149qXR-CTRQure.ai TechnologiesRadiologyQIH
09/22/2023K223659JazzAI Medical AGRadiologyLLZ
09/22/2023K231384Annalise Enterprise CTB Triage TraumaAnnalise-AI Pty Ltd.RadiologyQAS
09/21/2023K231678Overjet Periapical Radiolucency AssistOverjet, IncRadiologyMYN
09/19/2023K231281Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems CorporationRadiologyJAK
09/19/2023K221309AI100 with ShonitSigTuple Technologies Pvt. Ltd.HematologyJOY
09/14/2023K220034NEUROShieldIn-Med Prognostics L3CRadiologyLLZ
09/13/2023K223811Lung-CADImagen Technologies, IncRadiologyMYN
09/12/2023K231748Cartesion Prime (PCD-1000A/3) V10.15Canon Medical Systems CorporationRadiologyKPS
09/12/2023K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems CorporationRadiologyJAA
09/09/2023K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AGNeurologyHAW
09/08/2023K231335Cleerly ISCHEMIACleerly, IncCardiovascularQXZ
09/08/2023K232686CorVista® SystemCorVista Health, Inc.CardiovascularQXX
09/08/2023K222921Minuteful-kidney testHealthy.io Ltd.Clinical ChemistryJIR
09/08/2023K223621DeepXrayAlpha Intelligence Manifolds, Inc.RadiologyQIH
09/07/2023K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc.CardiovascularDQK
09/06/2023K232482MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.RadiologyLNH
09/01/2023K223622FaceHeart Vitals Software Development Kit (FH vitals SDK)FaceHeart Corp.CardiovascularQME
08/30/2023K230355Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiologyLNH
08/28/2023K223639VisAble.IOTechsoMedRadiologyQTZ
08/25/2023K223180AIRAscoreAIRAmed GmbHRadiologyLLZ
08/23/2023K230812Withings Scan Monitor 2.0WithingsCardiovascularDPS
08/22/2023K230899qXR-PTX-PEQure.ai TechnologiesRadiologyQFM
08/18/2023K223539Dreem 3SBeacon Biosignals, Inc.NeurologyOLZ
08/15/2023K231094Annalise Enterprise CTB Triage-OHAnnalise-AI Pty LtdRadiologyQAS
08/03/2023DEN230003Viz HCMViz.ai, Inc.CardiovascularQXO
08/03/2023K223133VisiRad XRImidex Inc.RadiologyMYN
08/02/2023K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AGNeurologyOLO
07/27/2023K231195Brainomix 360 Triage ICHBrainomix LimitedRadiologyQAS
07/27/2023K230074Rapid Aneurysm Triage and NotificationiSchemaView Inc.RadiologyQFM
07/26/2023K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLCCardiovascularQNL
07/26/2023K231572uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.RadiologyKPS
07/25/2023K230913ANDIImeka Solutions, Inc.RadiologyQIH
07/25/2023K223473ME-APDS™; MAGENTIQ-COLO™Magentiq Eye LTDGastroenterology-UrologyQNP
07/25/2023K230365Sonio DetectSonioRadiologyIYN
07/24/2023K223347UltraSight AI GuidanceUltraSight Inc.RadiologyQJU
07/21/2023K230150OptimMRIRebrAIn, SASRadiologyQIH
07/21/2023K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIBrainlab AGNeurologyHAW
07/21/2023K231173Irregular Rhythm Notification Feature (IRNF)Apple Inc.CardiovascularQDB
07/20/2023K230039uOmnispaceShanghai United Imaging Healthcare Co., LtdRadiologyQIH
07/19/2023K231157syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbHRadiologyOEB
07/14/2023K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion  (4.5);Fibertracking (2.0);BOLD MRI Mapping  (1.0);Image Fusion Angio  (1.0)Brainlab AGRadiologyQIH
07/14/2023K231757Ez3D-i /E3Ewoosoft Co., LtdRadiologyQIH
07/13/2023K231833Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc.RadiologyKPS
07/13/2023K223424Spine Auto ViewsGE Medical Systems SCSRadiologyJAK
07/13/2023K223426ECHELON Synergy MRI systemFUJIFILM Healthcare CorporationRadiologyLNH
07/12/2023K230823AusculThing ACCAusculThing OyCardiovascularDQD
07/10/2023K223724MOZI TPSManteia Technologies Co., Ltd.RadiologyMUJ
07/07/2023K231668Spine CAMP™ (1.1)Medical Metrics, Inc.RadiologyQIH
07/03/2023K222745Axial3D InsightAxial Medical Printing LimitedRadiologyQIH
06/29/2023DEN200052KidneyIntelX.dkdRenalytix AI, Inc.Clinical ChemistryQWZ
06/29/2023K230337EarliPointEarliTec Diagnostics, IncNeurologyQPF
06/22/2023K230497Bladder AI (AIBV01)Exo IncRadiologyQIH
06/20/2023K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty LtdRadiologyLNH
06/20/2023K230346Voluson SWIFT; Voluson SWIFT+GE Medical Systems Ultrasound & Primary Care Diagnostic, LLCRadiologyIYN
06/16/2023K223556DeepCatchMEDICALIP Co., LtdRadiologyQIH
06/16/2023K223646IB Lab LAMAIB Lab GmbHRadiologyQIH
06/16/2023K223357EyeArt v2.2.0Eyenuk, Inc.OphthalmicPIB
06/13/2023K230112CAC SoftwareImbio, Inc.RadiologyJAK
06/06/2023K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFEops nvRadiologyQIH
05/30/2023K223523Sonic DLGE Medical Systems,LLC (GE Healthcare)RadiologyLNH
05/25/2023K230273Saranas Early Bird Bleed Monitoring SystemSaranas Inc.CardiovascularQFJ
05/25/2023K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care SuiteGE Medical Systems, LLCRadiologyQBS
05/23/2023K223504Ceribell Status Epilepticus MonitorCeribell, Inc.NeurologyOMB
05/23/2023K230096Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc.RadiologyQDQ
05/19/2023K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - AI LtdGastroenterology-UrologyQNP
05/19/2023K212758AutoplaqueCedars-Sinai Medical Center: AIMRadiologyLLZ
05/17/2023K222728Radiation Planning Assistant (RPA)University of Texas, MD Anderson Cancer CenterRadiologyMUJ
05/12/2023K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLCRadiologyIYN
05/11/2023K223623SubtleMR (2.3.x)Subtle Medical Inc.RadiologyLLZ
05/10/2023K220437Neurophet AQUANEUROPHET, Inc.RadiologyLLZ
05/04/2023K230082Auto SegmentationGE Medical Systems, LLCRadiologyQKB
05/04/2023K223771Lumify Diagnostic Ultrasound SystemPhilips UltrasoundRadiologyIYN
05/02/2023K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., LtdCardiovascularQDA
05/02/2023K230977SIS SystemSurgical Information Sciences, Inc.RadiologyQIH
04/28/2023P210011xT CDxTempus Labs, Inc.PathologyPQP
04/27/2023K223212Precision DLGE HealthcareRadiologyKPS
04/27/2023K223734ENT EMBrainlab AGNeurologyPGW
04/26/2023K230552MR DWI/FLAIR Measurement V1.0Olea MedicalRadiologyLLZ
04/26/2023K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.CardiovascularMXD
04/25/2023K230223iCAC DeviceBunkerhill, IncRadiologyJAK
04/25/2023K222676Ceevra Reveal 3Ceevra, Inc.RadiologyQIH
04/21/2023K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison CO., LTD.RadiologyIYN
04/21/2023K223501ViewFinder Software Version 1.1Elaitra LtdRadiologyQIH
04/20/2023K223287VelacurSonic IncytesRadiologyIYO
04/20/2023K230807Deep Learning Image ReconstructionGE Healthcare Japan CorporationRadiologyJAK
04/19/2023K230023ART-PlanTherapanacea SASRadiologyQKB
04/19/2023K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning CranialBrainlab AGNeurologyHAW
04/17/2023K230772Quantib ProstateQuantib BVRadiologyLLZ
04/14/2023K230685AutoContour Model RADAC V3Radformation, Inc.RadiologyQKB
04/13/2023K230264Ezra FlashEzra AI, Inc.RadiologyLLZ
04/13/2023K213986CerebralGo PlusYukun (Beijing) Technology Co., LtdRadiologyQIH
04/11/2023K223830Ultrasound System 2300BK Medical ApsRadiologyIYN
04/07/2023K230658SKOUT® systemIterative Scopes Inc.Gastroenterology-UrologyQNP
04/07/2023K230575Limbus ContourLimbus AI Inc.RadiologyLLZ
04/06/2023K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.RadiologyJAK
04/06/2023K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.RadiologyLNH
04/06/2023K223774Contour ProtégéAIMIM Software Inc.RadiologyQKB
04/05/2023K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification SystemMedtronic, Inc.CardiovascularMXD
04/03/2023K223240Annalise Enterprise CTB Triage TraumaAnnalise-AI Pty LtdRadiologyQAS
03/31/2023K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.RadiologyIYO
03/31/2023K213272Formus HipFormus Labs, LtdRadiologyQIH
03/31/2023DEN200011Masimo SafetyNetMasimo CorporationAnesthesiologyQVT
03/29/2023K222312RayStation 12ARaySearch Laboratories AB (publ)RadiologyMUJ
03/28/2023K221921DTX Studio Clinic 3.0Nobel Biocare ABRadiologyMYN
03/28/2023K222174RadioLens v1.0SynapsicaRadiologyQIH
03/28/2023K222179Annalise Enterprise CXR Triage TraumaAnnalise-AI Pty LtdRadiologyQFM
03/28/2023K222268Annalise Enterprise CXR Triage TraumaAnnalise-AI Pty LtdRadiologyQFM
03/28/2023K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA Inc.RadiologyLNH
03/27/2023K222746Overjet Caries AssistOverjet, Inc.RadiologyMYN
03/22/2023K222036MPXA-2000Medipixel, Inc.RadiologyQIH
03/21/2023K223490FlightPlan for EmbolizationGE Medical Systems SCSRadiologyLLZ
03/17/2023K223443Viz AAAViz. ai, Inc.RadiologyQFM
03/17/2023K223073AlioAlio, Inc.CardiovascularDRG
03/17/2023K221772NeuroRPMNew Touch Digital Inc.NeurologyGYD
03/10/2023K223325uMI PanoramaShanghai United Imaging Healthcare Co., Ltd.RadiologyKPS
03/09/2023K223514Spectral Bone MarrowGE Medical Systems, LLCRadiologyJAK
03/09/2023K221706AccuContourManteia Technologies Co., Ltd.RadiologyQKB
03/07/2023K223726Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems CorporationRadiologyJAK
03/03/2023K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems CorporationRadiologyJAK
03/02/2023K222176BoneViewGleamerRadiologyQBS
03/02/2023K222884Rapid NCCT StrokeiSchemaView, Inc.RadiologyQAS
03/01/2023K221680Xeleris V Processing and Review SystemGE HealthcareRadiologyLLZ
02/24/2023DEN220063Caption Interpretation Automated Ejection Fraction SoftwareCaption Health, IncRadiologyQVD
02/24/2023K221592AVIEW Lung Nodule CADCoreline Soft Co.,Ltd.RadiologyOEB
02/23/2023K222579Belun Sleep System BLS-100Belun Technology Company LimitedAnesthesiologyMNR
02/23/2023K221564Brainomix 360 e-ASPECTSBrainomix LimitedRadiologyPOK
02/22/2023K230197BoneMRI v1.6MRIguidance B.V.RadiologyQIH
02/22/2023K230208Swoop® Portable MR Imaging System™Hyperfine, Inc.RadiologyLNH
02/17/2023DEN210022PMD-200Medasense Biometrics Ltd.AnesthesiologyQVE
02/16/2023K223028uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.RadiologyJAK
02/16/2023K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.RadiologyLNH
02/15/2023K222389ZEUS SystemiRhythm Technologies, Inc.CardiovascularDQK
02/13/2023K223439SIGNA VictorGE Healthcare (Tianjin) Company LimitedRadiologyLNH
02/13/2023K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
02/06/2023K223296Videa Perio AssistVideaHealth, Inc.RadiologyQIH
02/02/2023K222803OncospaceOncospace, Inc.RadiologyMUJ
02/01/2023K222970LVivo IQSDiA Imaging Analysis LtdRadiologyQIH
02/01/2023K223396Rapid RV/LViSchema View Inc.RadiologyQIH
02/01/2023K230020BriefCaseAidoc Medical, Ltd.RadiologyQFM
01/27/2023K221868QOCA image Smart CXR Image Processing SystemQuanta Computer Inc.RadiologyQFM
01/23/2023K222406Clarius AIClarius Mobile Health Corp.RadiologyQIH
01/21/2023K223516VX1+Volta MedicalCardiovascularDQK
01/18/2023K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.RadiologyLLZ
01/13/2023K223502MR Diffusion Perfusion Mismatch V1.0Olea MedicalRadiologyLLZ
01/12/2023K222458AIBOLIT 3D+Aibolit Technologies, LLCRadiologyLLZ
01/11/2023K223738Alpha Control Liner System (ACLS)CoaptNeurologyGXY
12/23/2022K214036AVIEWCoreline Soft Co.,Ltd.RadiologyQIH
12/23/2022K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V.RadiologyLNH
12/22/2022K223311Philips CT 3500Philips Healthcare (Suzhou) Co., LtdRadiologyJAK
12/16/2022K220928Overjet Calculus AssistOverjet Inc.RadiologyMYN
12/16/2022K223268BrainInsightHyperfine, Inc.RadiologyQIH
12/16/2022K222275Saige-DensityDeepHealth, Inc.RadiologyQIH
12/06/2022K223247Swoop Portable MR Imaging SystemHyperfine, Inc.RadiologyLNH
12/05/2022K222692BriefCaseAidoc Medical, Ltd.RadiologyQFM
12/01/2022K220786STAR Apollo Mapping SystemRhythm Al, LtdCardiovascularDQK
11/22/2022K221624Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc.RadiologyPOK
11/22/2022K221716CINAAVICENNA.AIRadiologyQAS
11/21/2022K223032SIS System (Version 5.6.0)Surgical Information Sciences, Inc.RadiologyQIH
11/18/2022K221330BriefCaseAidoc Medical, Ltd.RadiologyQAS
11/16/2022K221762BoneMRI v1.4MRlguidance B.V.RadiologyQIH
11/14/2022K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.RadiologyQIH
11/10/2022K220408AVIEW RT ACSCoreline Soft Co.,LtdRadiologyQKB
11/10/2022K221183AEYE-DSAEYE Health, Inc.OphthalmicPIB
11/08/2022K221552EFAI ChestSuite XR Pneumothorax Assessment SystemEver Fortune AI Co., Ltd.RadiologyQFM
10/31/2022P210015Avive Automated External Defibrillator (AED) SystemAvive Solutions, Inc.CardiovascularMKJ
10/27/2022K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co.,Ltd.RadiologyLNH
10/25/2022K222070EndoNautTherenva SASRadiologyOWB
10/21/2022K223042Viz LVO ContaCTViz.ai, Inc.RadiologyQAS
10/20/2022K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.RadiologyJAK
10/18/2022K221632Spine CAMP™Medical Metrics, Inc.RadiologyQIH
10/18/2022DEN220024ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound LimitedAnesthesiologyQRG
10/14/2022K213857HeartFlow AnalysisHeartFlow, Inc.CardiovascularPJA
10/14/2022K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, IncRadiologyQKB
10/07/2022K220709BriefCaseAidoc Medical, Ltd.RadiologyQAS
10/06/2022K221449Genius AI Detection 2.0Hologic, Inc.RadiologyQDQ
10/05/2022K221892VISIONAIRPacificMD Biotech LlcAnesthesiologyBXQ
09/30/2022K211611QIR SuiteCASIS Cardiac Simulation & Imaging SoftwareRadiologyQIH
09/29/2022K220080CogNet QmTRIAGEMedCognetics, Inc.RadiologyQFM
09/28/2022K222329BriefCaseAidoc Medical, Ltd.RadiologyQAS
09/27/2022K221738NS-HGlioNeosoma Inc.RadiologyQIH
09/21/2022K221179SomnoMetryNeumetry Medical IncNeurologyOLZ
09/20/2022K213353Aorta-CADImagen Technologies, IncRadiologyMYN
09/13/2022K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitSiemens Medical Solutions USA, Inc.RadiologyLNH
09/12/2022K221456Rapid ICHiSchemaView Inc.RadiologyQAS
09/12/2022K220986Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems CorporationRadiologyJAK
09/08/2022K222076EFAI ChestSuite XR Pleural Effusion Assessment SystemEver Fortune.AI Co., Ltd.RadiologyQFM
09/07/2022K220783syngo.via RT Image SuiteSiemens Medical Solutions USA Inc.RadiologyMUJ
09/06/2022K213960LiverMultiScan v5 (LMSv5)PerspectumRadiologyLNH
09/01/2022K221241DrAid for Radiology v1VinBrain Joint Stock CompanyRadiologyQFM
08/29/2022K221100Viz RV/LVViz.ai, Inc.RadiologyQIH
08/26/2022K222277BriefCaseAidoc Medical, Ltd.RadiologyQAS
08/25/2022K211841MRI PlannerSpectronic Medical ABRadiologyMUJ
08/25/2022K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.CardiovascularMXD
08/24/2022K220598AutoContour Model RADAC V2Radformation, Inc.RadiologyQKB
08/22/2022K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
08/19/2022K222172MI View&GOSiemens Medical Solutions USA, Inc.RadiologyQIH
08/12/2022K220349TeraRecon NeuroTeraRecon, IncRadiologyLLZ
08/12/2022K213686SKOUT SoftwareIterative Scopes Inc.Gastroenterology-UrologyQNP
08/11/2022K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmBhRadiologyJAK
08/08/2022K213645ClearPoint Maestro Brain ModelClearPoint Neuro, Inc.RadiologyQIH
08/03/2022K221432Customize3D-Side SARadiologyQIH
08/03/2022K221347Transpara 1.7.2ScreenPoint Medical B.V.RadiologyQDQ
07/29/2022K213760ABMD SoftwareHeartLung CorporationRadiologyKGI
07/29/2022K220961Deep Learning Image ReconstructionGE Healthcare Japan CorporationRadiologyJAK
07/28/2022K221923Swoop Portable MR Imaging SystemHyperfine, Inc.RadiologyLNH
07/28/2022K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging IncRadiologyQIH
07/27/2022K210822DeepRhythmAIMedicalgorithmics S.A.CardiovascularDQK
07/25/2022K220439Viz SDHViz.ai, Inc.RadiologyQAS
07/22/2022K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics,RadiologyQIH
07/22/2022K220624AI4CMR v1.0AI4MedImaging Medical Solutions S.A.RadiologyLLZ
07/22/2022K220882Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound andRadiologyIYN
07/20/2022K220956Libby Echo:PrioDyad Medical, IncRadiologyQIH
07/19/2022K220815BrainInsightHyperfine, Inc.RadiologyQIH
07/19/2022K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.CardiovascularDQK
07/19/2022K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences LLCCardiovascularDXH
07/18/2022K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics LLCRadiologyIYN
07/18/2022K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics,RadiologyIYN
07/15/2022K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics,RadiologyIYN
07/14/2022K221203AHI SystemFifth Eye Inc.CardiovascularQNV
07/13/2022K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.RadiologyJAK
07/08/2022K212783ProstatIDScanMed, LLCRadiologyQDQ
07/06/2022K210069Minuteful - kidney testHealthy.io Ltd.Clinical ChemistryJIR
06/29/2022K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
06/29/2022K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.CardiovascularDQD
06/27/2022K220851VenueGE Medical SystemsRadiologyIYN
06/27/2022K220848Venue FitGE Medical SystemsRadiologyIYN
06/24/2022K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.RadiologyLNH
06/23/2022K220497CoLumboSmart Soft Healthcare ADRadiologyQIH
06/21/2022K220800Venue GoGE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologyIYN
06/17/2022K213037IDx-DR v2.3Digital Diagnostics Inc.OphthalmicPIB
06/17/2022K220813ART-PLANTheraPanaceaRadiologyQKB
06/17/2022K221463ElucidVivo A.3Elucid Bioimaging Inc.RadiologyLLZ
06/16/2022K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001ACanon Medical Systems CorporationRadiologyJAK
06/10/2022K221393Swoop Portable MR Imaging SystemHyperfine, Inc.RadiologyLNH
06/08/2022K213882EarliPoint SystemEarliTec Diagnostics, Inc.NeurologyQPF
06/08/2022K213717AIR Recon DLGE Medical Systems,LLC (GE Healthcare)RadiologyLNH
06/06/2022K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics,RadiologyIYN
06/03/2022K221314BriefCaseAidoc Medical, Ltd.RadiologyQAS
06/03/2022K213971Atrial Fibrillation History FeatureApple Inc.CardiovascularQDB
06/02/2022K220164RayvolveAZmed SASRadiologyQBS
05/31/2022K221248Rapid LVOiSchemaView Inc.RadiologyQAS
05/31/2022K220766eMurmur Heart AICSD Labs GmbHCardiovascularDQD
05/25/2022K220416SwiftMRAIRS Medical Inc.RadiologyLLZ
05/17/2022K221240BriefCaseAidoc Medical, Ltd.RadiologyQAS
05/17/2022K220499Rapid PE Triage and Notification (PETN)iSchemaView Inc.RadiologyQAS
05/17/2022K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.RadiologyJAK
05/16/2022K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.RadiologyLNH
05/13/2022K221106Quantib ProstateQuantib BVRadiologyLLZ
05/13/2022K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.RadiologyLNH
05/12/2022K220105Saige-DxDeepHealth, Inc.RadiologyQDQ
05/11/2022K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics,RadiologyIYN
05/10/2022K212519Overjet Caries AssistOverjet, Inc.RadiologyMYN
05/06/2022K211966Segment 3DPrintMedviso ABRadiologyLLZ
05/03/2022K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs Ltd.HematologyJOY
05/03/2022K212915MVision AI SegmentationMVision AIRadiologyQKB
04/29/2022K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA Inc.RadiologyLNH
04/29/2022K220899Oxehealth Vital SignsOxehealth LimitedCardiovascularQME
04/29/2022K220590aPROMISE XEXINI Diagnostics ABRadiologyLLZ
04/28/2022K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.AI Co., Ltd.RadiologyQKB
04/27/2022K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd.RadiologyJAK
04/26/2022K212662AliveCor QT ServiceAliveCor, Inc.CardiovascularDQK
04/26/2022K213886BriefCaseAidoc Medical, Ltd.RadiologyQAS
04/22/2022K213944HealthOSTNanoxAI Ltd.RadiologyJAK
04/21/2022K213795Videa Caries AssistVideaHealth, IncRadiologyMYN
04/15/2022K213706AI-Rad Companion Brain MRSiemens Healthcare GmBhRadiologyQIH
04/15/2022K220141RayStation 11BRaySearch Laboratories AB (publ)RadiologyMUJ
04/08/2022K220192Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiologyLNH
04/08/2022K212274INT ContourCarina Medical LLCRadiologyMUJ
04/06/2022K203783ClariPulmoClariPi Inc.RadiologyLLZ
04/05/2022K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., LTDRadiologyIYN
04/05/2022K214081MRCAT Head & NeckPhilips OyRadiologyMUJ
04/04/2022K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune. AI Co., Ltd.RadiologyQIH
04/01/2022K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.RadiologyLNH
04/01/2022K213657DEEPVESSEL FFRKeyaMed NA Inc.CardiovascularPJA
03/22/2022K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems CorporationRadiologyIYN
03/22/2022K200828Athelas HomeAthelas Inc.HematologyGKZ
03/21/2022K213721BriefCaseAidoc Medical, Ltd.RadiologyQAS
03/16/2022K213779Customize3D-Side SARadiologyQIH
03/14/2022K214043BriefCaseAidoc Medical, Ltd.RadiologyQFM
03/14/2022K203744Arterys MICAArterys Inc.RadiologyQIH
03/11/2022K213725CardIQ SuiteGE Medical Systems SCSRadiologyJAK
03/10/2022K213566ClearRead Xray PneumothoraxRiverain Technologies, Inc.RadiologyQFM
03/04/2022K210365Second OpinionPearl Inc.RadiologyMYN
03/01/2022K212365BoneViewGleamerRadiologyQBS
02/25/2022K213693MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc.RadiologyLNH
02/24/2022K213941Annalise Enterprise CXR Triage PneumothoraxAnnalise-AIRadiologyQFM
02/18/2022K213319Viz ANEURYSM, Viz ANXViz.ai, Inc.RadiologyQFM
02/18/2022K213999Deep Learning Image ReconstructionGE Medical Systems, LLC.RadiologyJAK
02/17/2022K213689Voluson P6, Voluson P8GE HealthcareRadiologyIYN
02/11/2022K213603SIGNA Artist EvoGE Healthcare(Tianjin) Company LimitedRadiologyLNH
02/08/2022K213165RapidiSchema View Inc.RadiologyLLZ
02/04/2022K212654Micro C Medical Imaging System, M01OXOS Medical, Inc.RadiologyIZL
02/04/2022K213938Revolution AscendGE Healthcare Japan CorporationRadiologyJAK
02/03/2022K213976Contour ProtégéAIMIM Software Inc.RadiologyQKB
01/28/2022K203260syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc.RadiologyQAS
01/24/2022K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems CorporationRadiologyIYN
01/20/2022K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.RadiologyJAK
01/20/2022K213668SIGNA HeroGE Healthcare (GE Medical Systems, LLC)RadiologyLNH
01/19/2022K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption HealthRadiologyQIH
01/19/2022K212012Follicle ClarityCycle ClarityRadiologyQIH
01/16/2022K211980SIGNA PrimeGE Healthcare (Tianjin) Company LimitedRadiologyLNH
01/14/2022K210760Precise ImagePhilips Medical Systems Nederland, B.V.RadiologyJAK
01/14/2022K213307Eclipse II with Smart Noise CancellationCarestream Health, Inc.RadiologyMQB
01/14/2022K213737Quantib NDQuantib B.V.RadiologyLLZ
01/13/2022K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE HealthcareRadiologyIYN
01/12/2022K212005UNiD Spine AnalyzerMEDICREA International, Inc.RadiologyLLZ
01/07/2022K211443AIBOLIT 3D+AIbolit Technologies, LLCRadiologyLLZ
01/06/2022K213544TOMTEC-ARENATOMTEC Imaging Systems GmbHRadiologyQIH
12/29/2021K213776LiverSmartResonance Health Analysis Services Pty LtdRadiologyPCS
12/22/2021K202404BoneMRIMRIguidance B.VRadiologyQIH
12/21/2021K212690qXR-BTQure.ai TechnologiesRadiologyQIH
12/21/2021K210670BU-CADTaiHao Medical Inc.RadiologyQDQ
12/20/2021K213275EchoGo Core (2.0)Ultromics LimitedRadiologyQIH
12/16/2021K213628VBrainVysioneer Inc.RadiologyQKB
12/16/2021K212616Koios DSKoios Medical, Inc.RadiologyPOK
12/15/2021K213155RT-Mind-AIMedMind Technology Co., Ltd.RadiologyQKB
12/15/2021K211803HealthPPTZebra Medical Vision Ltd.RadiologyQFM
12/09/2021K212466LVivo SeamlessDiA Imaging Analysis LtdRadiologyQIH
12/06/2021K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.RadiologyJAK
12/03/2021K212219AHI SystemFifth Eye Inc.CardiovascularQNV
12/03/2021K212442Cydar EV (Series B) and Cydar EV MapsCydar Ltd.RadiologyOWB
12/01/2021K213305Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems CorporationRadiologyLNH
11/26/2021K211541MammoScreen 2.0TherapixelRadiologyQDQ
11/19/2021K210831OnQ NeuroCorTechs Labs, IncRadiologyQIH
11/19/2021K211326EndoScreenerChengdu Wision Medical Device Co., LTD.Gastroenterology-UrologyQNP
11/17/2021K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc.RadiologyLNH
11/17/2021K212336Soteria.AIOmega Medical Imaging, LLCRadiologyOWB
11/17/2021K211678Lunit INSIGHT MMGLunit Inc.RadiologyQDQ
11/16/2021K212265TEX20/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 SystemShenzhen Mindray Bio-Medical Electronics Co.,LTDRadiologyIYN
11/15/2021K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.RadiologyIYN
11/10/2021K211733Lunit INSIGHT CXR TriageLunit Inc.RadiologyQFM
11/03/2021K210543IM007Implicity, Inc.CardiovascularDQK
10/29/2021K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGE Medical Systems, LLCRadiologyQIH
10/25/2021K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions ABRadiologyQKB
10/22/2021K210807FlightPlan for LiverGE Medical Systems SCSRadiologyLLZ
10/22/2021K212516IRNF AppApple Inc.CardiovascularQDB
10/20/2021K210632Contour ProtegeAIMIM Software Inc.RadiologyQKB
10/14/2021K210999SwiftMRAIRS Medical Inc.RadiologyLLZ
10/14/2021K212261StrokeSENS LVOCircle Neurovascular Imaging, IncRadiologyQAS
10/12/2021K212116VBrain-OARVysioneer Inc.RadiologyQKB
10/02/2021K202927EYE-SYNCSyncThink, Inc.NeurologyQEA
09/28/2021K211964SubtlePETSubtle Medical, Inc.RadiologyKPS
09/24/2021K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical SystemsRadiologyIYN
09/21/2021DEN200080Paige ProstatePaige.AIPathologyQPN
09/17/2021K212067Deep Learning Image ReconstructionGE Healthcare Japan CorporationRadiologyJAK
09/17/2021K212269Intelligent NRCanon Inc.RadiologyMQB
09/15/2021K210085HealthCCSngZebra Medical Vision Ltd.RadiologyJAK
09/10/2021K203785ClariSIGMAMClariPi Inc.RadiologyQIH
09/10/2021K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics,RadiologyIYN
09/10/2021K211828Aquilion Exceed LBCanon Medical Systems CorporationRadiologyJAK
09/09/2021K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.RadiologyIYN
09/08/2021K211945V8 Diagnostic Ultrasound SystemSamsung Medison CO., LTD.RadiologyIYN
09/08/2021DEN200030FEops HEARTguideFEops NVCardiovascularQQI
09/08/2021K203555AmCAD-UTAmCad BioMed CorporationRadiologyQIH
09/08/2021K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical SystemsRadiologyIYN
09/08/2021K211867RayStation 11.0RaySearch Laboratories AB (publ)RadiologyMUJ
09/02/2021K211881AI SegmentationVarian Medical Systems, Inc.RadiologyMUJ
08/31/2021K201560Auto Lung Nodule DetectionSamsung Electronics Co.,Ltd.RadiologyMYN
08/31/2021K212383EndoNautTherenva SASRadiologyOWB
08/27/2021K203696RBkneeRadiobotics ApSRadiologyLLZ
08/20/2021K211846Discovery MI Gen2GE Medical Systems, LLC.RadiologyKPS
08/16/2021K212230TruSPECT  Radiological Image Processing StationSpectrum Dynamics Medical LtdRadiologyLLZ
08/12/2021K211179InferRead CT Stroke.AIInfervision Medical Technology Co., Ltd.RadiologyQAS
08/11/2021K203448uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.RadiologyJAK
08/06/2021K211764Vereos PET/CTPhilips Medical Systems Nederland B.V.RadiologyKPS
08/06/2021K212100KosmosEchoNous, Inc.RadiologyIYN
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11/20/2020K200873HALONICo-Lab B.V.RadiologyQAS
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12/20/2019K192383BriefCaseAidoc Medical, Ltd.RadiologyQAS
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12/10/2019K192287TransparaScreenpoint Medical B.V.RadiologyQDQ
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11/05/2019K192109KOALAIB Lab GmbHRadiologyLLZ
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10/04/2019K191994ProFound AI Software V2.1iCAD Inc.RadiologyQDQ
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08/29/2019K183489D2P3D Systems, Inc.RadiologyLLZ
08/29/2019K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.RadiologyIYN
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08/15/2019K190925HeartFlow FFRct AnalysisHeartFlow, Inc.CardiovascularPJA
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07/31/2019K191183EyeBOXOculogica, Inc.NeurologyQEA
07/26/2019K182384ACR  LAB Urine Analysis Test SystemHealthy.io LtdClinical ChemistryJFY
07/26/2019K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.RadiologyJAK
07/19/2019K182798KIDScore D3Vitrolife A/SObstetrics and GynecologyPBH
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05/06/2019K190362HealthPNXZebra Medical Vision  Ltd.RadiologyQFM
04/22/2019K182513FluChip-8G Influenza A+B AssayInDevR, Inc.MicrobiologyOZE
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04/17/2019K181988eMurmur IDCSD Labs GmbHCardiovascularDQD
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01/18/2019K183231SIGNA PremierGE Medical Systems, LLCRadiologyLNH
01/17/2019K182456Study WatchVerily Life Sciences LLCCardiovascularDXH
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12/28/2018K180867AmCAD-UOAmCad BioMed CorporationRadiologyLLZ
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12/27/2018K182130iSchemaView RAPIDiSchemaView, Inc.RadiologyLLZ
12/21/2018K183012vascuCAPElucid Bioimaging Inc.RadiologyLLZ
12/20/2018K181861EmbraceEmpatica SrlNeurologyPOS
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