SaMD Cleared by the FDA: The Ultimate Running List

Randy Horton
Randy Horton

This list, created by Orthogonal and Brian Binkowski, contains information on 562 individual Software as a Medical Devices (SaMD) cleared by the FDA. The data used to create this list was pulled from publicly available sources such archived reports from the FDA and Basil System’s regulatory search tools. As this list is a work in progress, we invite members of the MedTech and digital health industries to submit comments and revisions in order to improve its accuracy. Submit comments via this form or email us at [email protected].

Learn about the methodology used to create this list by reading our accompanying blog.

List of FDA-Cleared SaMD

CompanyDate of Final DecisionDevicePanel (Lead)
BioTraceIO LiteTechsoMed Medical Technologies Ltd12/22/23Radiology
qXR-LNQure.Ai Technologies12/22/23Radiology
Body Temperature Software (BTS)Fitbit LLC12/15/23General Hospital
Videa Dental AssistVideaHealth, Inc.12/15/23Radiology
Insulia Bolus CompanionVoluntis SA.12/12/23General Hospital
NaviCam ProScanAnkon Technologies Co., Ltd12/12/23Gastroenterology/Urology
Clearpoint System (Software Version 2.2)Clearpoint Neuro, Inc.11/27/2023Neurology
Brainomix 360 Triage StrokeBrainomix Limited11/21/2023Radiology
NemocastSoftware Nemotec S.L.11/21/2023Dental
Ai Platform (Aip001)Exo Inc11/17/2023Radiology
Axial3D InsightAxial Medical Printing Limited11/15/2023Radiology
Briefcase-QuantificationAidoc Medical, Ltd.11/13/2023Radiology
Clarius Bladder AIClarius Mobile Health Corp.11/13/2023Radiology
Briefcase-QuantificationAidoc Medical, Ltd.11/8/2023Radiology
Contour ProtegeAIMim Software, Inc.11/8/2023Radiology
Lunit Insight DbtLunit Inc.11/6/2023Radiology
Aprevo® Digital SegmentationCarlsmed, Inc11/3/2023Radiology
SwiftMRAirs Medical Inc.10/27/2023Radiology
Signalhf (Im008)Implicity Inc.10/25/2023Cardiovascular
AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc10/23/2023Radiology
Sonix HealthOntact Health Co., Ltd.10/20/2023Radiology
Smartbolus CalculatorInsulet Corporation10/18/2023Clinical Chemistry
Titan Dental DesignClearadvance, LLC10/13/2023Dental
Artemis, Artemis Tpo, Artemis MxEigen10/12/2023Radiology
Scannav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited10/6/2023Anesthesiology
Vivio® LVEDP SystemAvicena, LLC10/6/2023Cardiovascular
Denti.AI DetectDenti.AI Technology, Inc.10/6/23Radiology
Cmangio® V1.0Curemetrix, Inc.10/5/2023Radiology
DeepTek CXR Analyzer v1.0DeepTek Medical Imaging Pvt Ltd10/5/23Radiology
Vuno Med-DeepbrainVuno Inc.10/4/2023Radiology
Lung-CADImagen Technologies, Inc10/3/23Radiology
Terran Nm-101Terran Biosciences, Inc.9/29/2023Radiology
Brainomix 360 Triage LVOBrainomix Limited9/28/2023Radiology
Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc.9/28/2023Cardiovascular
JazzAi Medical AG9/22/2023Radiology
Rology Teleradiology Platform (V.1.22.1103)Rology Inc.9/20/2023Radiology
Impact Version 4Impact Applications, Inc.9/16/2023Neurology
Lung-CADImagen Technologies, Inc9/13/23Radiology
Cleerly IschemiaCleerly, Inc9/8/2023Cardiovascular
Unisyn Molecular Imaging (6-3-1)Convergent Imaging Solutions9/1/2023Radiology
Visable.IoTechsomed8/28/2023Radiology
AIRAscoreAIRAmed GmbH8/25/2023Radiology
Natural CyclesNatural Cycles Nordic AB8/24/2023Obstetrics/Gynecology
LifeShield™ Infusion Safety Software SuiteICU Medical, Inc8/24/23General Hospital
CUPTIMIZE™ AdvancedDepuy Orthopaedics, Inc8/22/2023Radiology
Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart AppCochlear8/18/2023Ear Nose & Throat
Spark ScanSpark Neuro Inc.8/18/2023Neurology
Efai PACS Picture Archiving And Communication System ProEver Fortune.Ai Co., Ltd.8/8/2023Radiology
Visirad XrImidex Inc.8/3/2023Radiology
VisiRad XRImidex Inc.8/3/23Radiology
Viz HCMViz.Ai, Inc.8/3/23Cardiovascular
Bluestar And BlueStar RxWelldoc, Inc.7/28/2023Clinical Chemistry
Brainomix 360 Triage ICHBrainomix Limited7/27/2023Radiology
AndiImeka Solutions, Inc.7/25/2023Radiology
Sonio DetectSonio7/25/2023Radiology
UltraSight AI GuidanceUltraSight Inc.7/24/23Radiology
Irregular Rhythm Notification Feature (Irnf)Apple Inc.7/21/2023Cardiovascular
OptimMRIRebrain, Sas7/21/2023Radiology
UomnispaceShanghai United Imaging Healthcare Co., Ltd.7/20/2023Radiology
Syngo.Ct Lung CAD (Version Vd30)Siemens Healthcare GmbH7/19/2023Radiology
TrustRgorithm Korea7/18/2023Dental
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 Ag7/14/2023Radiology
Jivex (Model Number / Release: 5.4)Visus Health It GmbH7/14/2023Radiology
Spine Camp™ (1.1)Medical Metrics, Inc.7/7/2023Radiology
T3 Platform SoftwareEtiometry, Inc.7/7/2023Cardiovascular
BT-001Better Therapeutics7/7/23Clinical Chemistry
Axial3D InsightAxial Medical Printing Limited7/3/2023Radiology
KidneyIntelX.DkdRenalytix AI, Inc.6/29/23Clinical Chemistry
Blood Establishment Computer Software And AccessoriesGPI USA, Inc.6/26/2023Hematology
Bladder Ai (Aibv01)Exo Inc6/22/2023Radiology
Hepafatsmart (V2.0.0)Resonance Health Analysis Services Pty Ltd6/20/2023Radiology
Tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc.6/20/2023Anesthesiology
DeepcatchMedicalip Co., Ltd6/16/2023Radiology
Ib Lab LamaIb Lab GmbH6/16/2023Radiology
EyeArt v2.2.0Eyenuk, Inc6/16/23Ophthalmic
Cac SoftwareImbio, Inc.6/13/2023Radiology
IorthoShanghai Ea Medical Instruments Co., Ltd.6/13/2023Dental
Ablamapâ® SystemAblacon, Inc.6/8/2023Cardiovascular
FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops Nv6/6/2023Radiology
Huma RPM (RPM)Medopad Inc6/2/2023Cardiovascular
Huma RPM (RPM)Medopad Inc6/2/23Cardiovascular
Critical Care Suite With Pneumothorax Detection Ai Algorithm, Critical Care Suite 2.1, Critical Care SuiteGe Medical Systems, LLC5/25/2023Radiology
Adas 3DAdas3D Medical S.L5/23/2023Radiology
Genius Ai Detection 2.0 With Cc-Mlo CorrelationHologic, Inc.5/23/2023Radiology
AutoplaqueCedars-Sinai Medical Center5/19/2023Radiology
Deepx Dermosight DermatoscopeDeepx Health LLC5/17/2023General & Plastic Surgery
Subtlemr (2.3.X)Subtle Medical Inc.5/11/2023Radiology
StanzaSwing Therapeutics, Inc5/9/23Neurology
Auto SegmentationGe Medical Systems, LLC5/4/2023Radiology
Samsung ECG Monitor Application With Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd5/2/2023Cardiovascular
Sis SystemSurgical Information Sciences, Inc.5/2/2023Radiology
Carnalife HoloMedapp S.A.5/1/2023Radiology
Ceevra Reveal 3Ceevra, Inc.4/25/2023Radiology
ICAC DeviceBunkerhill, Inc4/25/2023Radiology
Viewfinder Software Version 1.1Elaitra Ltd4/21/2023Radiology
Art-PlanTherapanacea4/19/2023Radiology
Autocontour Model Radac V3Radformation, Inc.4/14/2023Radiology
Cerebralgo PlusYukun (Beijing) Technology Co., Ltd4/13/2023Radiology
Ezra FlashEzra Ai, Inc.4/13/2023Radiology
Limbus ContourLimbus Ai Inc.4/7/2023Radiology
Contour ProtegeAIMim Software, Inc.4/6/2023Radiology
Formus HipFormus Labs, Ltd3/31/2023Radiology
Masimo SafetyNetMasimo Corporation3/31/23Anesthesiology
Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation3/31/23General Hospital
Interview XP; Interview FusionMediso Medical Imaging Systems, Lttd.3/29/2023Radiology
Radiolens V1.0Synapsica3/28/2023Radiology
DTX Studio Clinic 3.0Nobel Biocare AB3/28/23Radiology
Mpxa-2000Medipixel, Inc.3/22/2023Radiology
Digital RoutinesGNC Holdings, LLC3/15/23General Hospital
AccucontourManteia Technologies Co., Ltd.3/9/2023Radiology
AccuFFRangio PlusArteryflow Technology Co., Ltd.3/2/2023Radiology
BoneviewGleamer3/2/2023Radiology
Rapid Ncct StrokeiSchemaView Inc.3/2/2023Radiology
AccuICASArteryflow Technology Co., Ltd.2/28/2023Radiology
Caption Interpretation Automated Ejection Fraction SoftwareCaption Health2/24/2023Radiology
Tytocare Lung Sounds AnalyzerTyto Care Ltd.2/24/2023Anesthesiology
Caption Interpretation Automated Ejection Fraction SoftwareCaption Health, Inc2/24/23Radiology
Brainomix 360 E-AspectsBrainomix Limited2/23/2023Radiology
3D-RD-SRadiopharmaceutical Imaging And Dosimetry, LLC2/22/2023Radiology
BoneMRI V1.6MRIguidance B.V2/22/2023Radiology
PMD-200Medasense Biometrics Ltd.2/17/2023Anesthesiology
PMD-200Medasense Biometrics Ltd.2/17/23Anesthesiology
Videa Perio AssistVideahealth, Inc2/6/2023Radiology
Atomica PlannerAtomica Technology, Inc.2/2/2023Radiology
Deltascan MonitorProlira B.V.2/2/2023Neurology
Lvivo IQSDia Imaging Analysis Ltd2/1/2023Radiology
Rapid Rv/LviSchemaView Inc.2/1/2023Radiology
Tinnitogram Signal GeneratorGoldenear Company, Inc.2/1/2023Ear Nose & Throat
Qoca Image Smart Cxr Image Processing SystemQuanta Computer Inc.1/27/2023Radiology
Sim&SizeSim&Cure1/27/2023Neurology
Clarius AIClarius Mobile Health Corp.1/23/2023Radiology
Tidepool LoopTidepool Project1/23/2023Clinical Chemistry
T3 Platform SoftwareEtiometry, Inc.1/6/2023Cardiovascular
AviewCoreline Soft Co.,Ltd.12/23/2022Radiology
BraininsightHyperfine, Inc.12/16/2022Radiology
Saige-DensityDeephealth, Inc.12/16/2022Radiology
Star Apollo Mapping SystemRhythm Al, Ltd12/1/2022Cardiovascular
Echogo Heart FailureUltromics Ltd.11/23/2022Cardiovascular
Avenda Health AI Prostate Cancer Planning SoftwareAvenda Health, Inc.11/22/2022Radiology
Sis System (Version 5.6.0)Surgical Information Sciences, Inc.11/21/2022Radiology
BoneMRI V1.4MRIguidance B.V11/16/2022Radiology
Syngo Dynamics (Version Va40F)Siemens Medical Solutions USA, Inc11/14/2022Radiology
AEYE-DSAEYE Health, Inc.11/10/22Ophthalmic
Luminopia OneLuminopia, Inc.11/4/2022Ophthalmic
Welch Allyn Connex Central StationWelch Allyn Inc.10/28/22Cardiovascular
UMR Omega With uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.10/27/2022Radiology
Intraop Vsp Software DeviceXironetic, LLC10/21/2022Radiology
Spine Camp™Medical Metrics, Inc.10/18/2022Radiology
AI-Rad Companion Organs RtSiemens Medical Solutions USA, Inc10/14/2022Radiology
Heartflow AnalysisHeartflow, Inc.10/14/2022Cardiovascular
Genius Ai Detection 2.0Hologic, Inc.10/6/2022Radiology
Blood Establishment Computer Software And AccessoriesDiagnostic Grifols, S. A.10/4/2022Hematology
QIR SuiteCasis Cardiac Simulation & Imaging Software9/30/2022Radiology
Cognet QmtriageMedcognetics, Inc.9/29/2022Radiology
Curesight-Cs100Novasight Ltd.9/29/2022Ophthalmic
Ns-HglioNeosoma Inc.9/27/2022Radiology
SomnometryNeumetry Medical Inc9/21/2022Neurology
Aorta-CADImagen Technologies, Inc9/20/22Radiology
EyeCTesterNeuro-Eye Diagnostic Systems LLC9/7/2022Ophthalmic
Dose IQ Safety SoftwareBaxter Healthcare Corporation8/30/22General Hospital
Viz Rv/LvViz.Ai, Inc.8/29/2022Radiology
MRI PlannerSpectronic Medical AB8/25/2022Radiology
Autocontour Model Radac V2Radformation, Inc.8/24/2022Radiology
MI View&GoSiemens Medical Solutions USA, Inc8/19/2022Radiology
NovoPathAI, INC.8/11/22Pathology
Clearpoint Maestro Brain ModelClearpoint Neuro, Inc.8/8/2022Radiology
Customize3D-Side SA8/3/2022Radiology
Transpara 1.7.2Screenpoint Medical B.V.8/3/2022Radiology
Cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging Inc7/28/2022Radiology
Cochlear Osia 2 System, Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitCochlear Americas7/27/2022Ear Nose & Throat
Echopac Software Only, Echopac Plug-InGe Medical Systems Ultrasound And Primary Care Diagnostics,7/22/2022Radiology
Libby Echo:PrioDyad Medical, Inc7/20/2022Radiology
BraininsightHyperfine, Inc.7/19/2022Radiology
Zeus System (Zio Watch)iRhythm Technologies, Inc.7/19/2022Cardiovascular
Naeotom Alpha, Scan&Go SoftwareSiemens Medical Solutions USA, Inc7/12/2022Radiology
ProstatidScanmed, LLC7/8/2022Radiology
Eko Murmur Analysis Software (EMAS)Eko Devices Inc6/29/22Cardiovascular
OtoplanCascination Ag6/24/2022Ear Nose & Throat
ColumboSmart Soft Healthcare Ad6/23/2022Radiology
T3 Platform SoftwareEtiometry, Inc.6/22/2022Cardiovascular
Art-PlanTherapanacea6/17/2022Radiology
IDx-DR v2.3Digital Diagnostics Inc6/17/22Ophthalmic
Atrial Fibrillation History FeatureApple Inc.6/3/2022Cardiovascular
eCareManager 4.5Visicu, Inc.6/3/2022Cardiovascular
RayvolveAzmed Sas6/2/2022Radiology
Efai Cardiosuite Spect Myocardial Perfusion Agile WorkflowsEver Fortune.Ai Co., Ltd.5/31/2022Radiology
Rapid LvoiSchemaView Inc.5/31/2022Radiology
SwiftMRAirs Medical Inc.5/25/2022Radiology
On3D3D Ons, Inc.5/23/2022Radiology
Saige-DxDeephealth, Inc.5/12/2022Radiology
Overjet Caries AssistOverject Inc.5/10/22Radiology
MVision AI SegmentationMVision AI5/3/2022Radiology
Efai RTsuite Ct Hn-Segmentation SystemEver Fortune.Ai Co., Ltd.4/28/2022Radiology
Alivecor QT ServiceAlivecor, Inc.4/26/2022Cardiovascular
CER-SCardiocalm4/25/2022Cardiovascular
Videa Caries AssistVideaHealth, Inc4/21/2022Radiology
AI-Rad Companion Brain MRSiemens Healthcare GmbH4/15/2022Radiology
Fitbit Irregular Rhythm NotificationsFitbit Inc4/8/2022Cardiovascular
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai Co., Ltd.4/4/2022Radiology
Deepvessel FfrKeyamed Na Inc.4/1/2022Cardiovascular
Customize3D-Side SA3/16/2022Radiology
Arterys MICAArterys Inc.3/14/2022Radiology
Demetra Dermatoscope BDEM-01Barco Nv3/11/2022General & Plastic Surgery
RI.Hip ModelerBlue Belt Technologies, Inc.3/11/2022Radiology
Second OpinionPearl Inc.3/4/22Radiology
BoneviewGleamer3/1/2022Radiology
Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG3/1/22General Hospital
Zyter RPMZyter, Inc.2/11/2022Cardiovascular
RapidiSchemaView Inc.2/8/2022Radiology
Micro C Medical Imaging System, M01Oxos Medical, Inc.2/4/2022Radiology
Veuron-Brain-Pab2Heuron Co., Ltd.2/4/2022Radiology
Contour ProtegeAIMim Software, Inc.2/3/2022Radiology
Caption Interpretation Automated Ejection Fraction SoftwareCaption Health1/19/2022Radiology
Follicle ClarityCycle Clarity1/19/2022Radiology
Eclipse Ii With Smart Noise CancellationCarestream Health, Inc1/14/2022Radiology
Precise ImagePhilips Medical Systems Nederland, B.V.1/14/2022Radiology
Capsule Surveillance SystemCapsule Surveillance Technologies, SAS /Capsule Tech, Inc.1/14/22Cardiovascular
Unid Spine AnalyzerMedicrea International, Inc.1/12/2022Radiology
Tomtec-ArenaTomtec Imaging Systems GmbH1/6/2022Radiology
BoneMRIMRIguidance B.V12/22/2021Radiology
Claritas IpetClaritas Healthtech Pte Ltd12/22/2021Radiology
BU-CADTaihao Medical Inc.12/21/2021Radiology
qXR-BTQure.Ai Technologies12/21/2021Radiology
Echogo Core (2.0)Ultromics Ltd.12/20/2021Radiology
Archform Orthodontic Software SystemArchform, Inc12/16/2021Dental
Koios DSKoios Medical, Inc.12/16/2021Radiology
VbrainVysioneer Inc.12/16/2021Radiology
Rt-Mind-AIMedmind Technology Co., Ltd.12/15/2021Radiology
LVivo Seamless V2.0Dia Imaging Analysis Ltd12/9/2021Radiology
ImplastationProdigident, Inc.12/3/2021Radiology
EncevisAustrian Institute Of Technology GmbH12/2/2021Neurology
Mammoscreen 2.0Therapixel11/26/2021Radiology
ReguloraMetame Health, Inc.11/24/2021Gastroenterology/Urology
Hypotension Decision Assist Model Hda-Or2Directed Systems Ltd11/23/2021Cardiovascular
Myomics QPhantomics Inc.11/23/2021Radiology
EndoScreenerChengdu Wision Medical Device Co., Ltd.11/19/2021Gastroenterology/Urology
ONQ NeuroCortechs Labs, Inc.11/19/2021Radiology
Lunit Insight MmgLunit Inc.11/17/2021Radiology
Intellijoint ViewIntellijoint Surgical Inc.11/12/2021Radiology
RTappSegana, Inc.11/10/2021Radiology
Hura CTP v1.0Hura Imaging, Inc.11/8/2021Radiology
Critical Care Suite With Endotracheal Tube Positing Ai AlgorithmGe Medical Systems, LLC10/29/2021Radiology
EndoTool SubQ 2.1Monarch Medical Technologies, LLC10/28/21General Hospital
Advanced Algorithms For Treatment Management Applications (Aatma)Elekta Solutions Ab10/25/2021Radiology
IRNF AppApple Inc.10/22/2021Cardiovascular
Contour ProtegeAIMim Software, Inc.10/20/2021Radiology
iRADClaritas Healthtech Pte Ltd10/20/2021Radiology
SwiftMRAirs Medical Inc.10/14/2021Radiology
Vbrain-OarVysioneer Inc.10/12/2021Radiology
Brius Planner SoftwareBrius Technologies Inc10/1/2021Dental
Naeotom Alpha, Scan&GoSiemens Medical Solutions USA, Inc9/30/2021Radiology
JiveX (Model Number / Release: 5.3)Visus Health It GmbH9/23/2021Radiology
Paige ProstatePaige.AI9/21/2021Pathology
Paige ProstatePaige.AI9/21/21Pathology
AccuFFRangioArteryflow Technology Co., Ltd.9/10/2021Radiology
ClariSIGMAMClaripi Inc9/10/2021Radiology
EFAI PACS Picture Archiving and Communication SystemEver Fortune.Ai Co., Ltd.9/10/2021Radiology
AmCAD-UTAmcad Biomed Corporation9/8/2021Radiology
BlueStar RxWelldoc, Inc.9/8/2021Clinical Chemistry
FEops HEARTguideFeops NV9/8/2021Cardiovascular
ADAS 3DAdas3D Medical S.L9/3/2021Radiology
Ablamap SoftwareAblacon, Inc.8/31/2021Cardiovascular
Auto Lung Nodule DetectionSamsung Electronics Co.,Ltd.8/31/21Radiology
RbkneeRadiobotics Aps8/27/2021Radiology
SureTune4 SoftwareMedtronic Neuromodulation8/23/21Neurology
OtoplanCascination Ag8/20/2021Ear Nose & Throat
Breastscape V1.0Olea Medical8/2/2021Radiology
qER-QuantQure.Ai Technologies7/30/2021Radiology
Us2.V1Eko.Ai Pte. Ltd. D/B/A Us2.Ai7/27/2021Radiology
Change Healthcare Anatomical AiChange Healthcare Canada Company7/20/2021Radiology
Chest-CADImagen Technologies, Inc07/20/2021Radiology
Powerlook Density Assessment Software V4.0Icad Inc.7/12/2021Radiology
Pre-SureLazarus, 3D, Inc7/8/2021Radiology
Natural CyclesNatural Cycles Nordic AB6/24/2021Obstetrics/Gynecology
CodiagnostixDental Wings GmbH6/21/2021Dental
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.6/11/2021Cardiovascular
Syngo.Via Mi Workflows, Scenium, Syngo MbfSiemens Medical Solutions USA, Inc6/10/2021Radiology
IDx-DRDigital Diagnostics Inc6/10/21Ophthalmic
Insulia Diabetes Management CompanionVoluntis, S.A.6/4/21General Hospital
Transpara 1.7.0Screenpoint Medical B.V.6/2/2021Radiology
Overjet Dental AssistOverject Inc.5/19/21Radiology
MEDO-ThyroidMedo Dx Pte. Ltd.4/23/2021Radiology
Preview ShoulderGenesis Software Innovations4/21/2021Radiology
Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC4/20/2021Radiology
DV.TargetDeepvoxel, Inc.4/2/2021Radiology
syngo.CT Lung CAD (Version VD20)Siemens Healthcare GmbH3/31/2021Radiology
Oxehealth Vital SignsOxehealth Limited3/26/2021Cardiovascular
VbrainVysioneer Inc.3/19/2021Radiology
Profound AI Software V3.0Icad Inc.3/12/2021Radiology
Imbio RV/LV SoftwareImbio, LLC3/9/2021Radiology
Optellum Virtual Nodule Clinic, Optellum Software, Optellum PlatformOptellum Ltd3/5/2021Radiology
Analytic For Hemodynamic Instability (Ahi)Fifth Eye Inc.3/1/2021Cardiovascular
Analytic For Hemodynamic Instability (AHI)Fifth Eye Inc3/1/21Cardiovascular
CuptimizeCuptimize, Inc.2/26/2021Radiology
SubtleMRSubtle Medical Inc.2/26/2021Radiology
TruplanCircle Cardiovascular Imaging Inc2/19/2021Radiology
Clue Birth ControlBiowink GmbH2/18/2021Obstetrics/Gynecology
LVivo Software ApplicationDia Imaging Analysis Ltd2/5/2021Radiology
Visage Breast DensityVisage Imaging GmbH1/29/2021Radiology
Veuron-Brain-PabHeuron Co., Ltd.1/15/2021Radiology
Art-PlanTherapanacea1/14/2021Radiology
Heartflow AnalysisHeartflow, Inc.1/8/2021Cardiovascular
ImPACT Version 4ImPACT Applications, Inc.12/25/2020Neurology
Planimax Orthodontic SoftwareChoice Biotech Inc.12/22/2020Dental
EchoGo ProUltromics Ltd.12/18/2020Radiology
HepaFat-AIResonance Health Analysis Services Pty Ltd12/7/2020Radiology
T3 Platform softwareEtiometry, Inc.11/25/20Cardiovascular
Genius Ai DetectionHologic, Inc.11/18/2020Radiology
Coroflow Cardiovascular SystemCoroventis Research Ab11/13/2020Cardiovascular
KardiaAIAlivecor, Inc.11/12/2020Cardiovascular
AI-Rad Companion Organs RtSiemens Medical Solutions USA, Inc11/6/2020Radiology
Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.10/30/2020Cardiovascular
AutocontourRadformation, Inc.10/30/2020Radiology
Smart Alarm InterfaceBoxview, LLC10/30/2020Cardiovascular
WRDensity by Whiterabbit.aiWhiterabbit.Ai Inc.10/30/2020Radiology
Stethee Pro 1, Stethee Pro Software SystemM3Dicine Pty Ltd.10/9/2020Cardiovascular
LVivo SeamlessDia Imaging Analysis Ltd9/29/2020Radiology
Ventilator, Non-Continuous (Respirator)Respironics, Inc.9/25/2020Anesthesiology
Halo AF Detection SystemLivmor9/23/2020Cardiovascular
Halo AF Detection SystemLIVMOR9/23/20Cardiovascular
Caption GuidanceCaption Health9/18/20Radiology
3Shape Implant Studio3Shape Medical A/S9/9/2020Radiology
CER-SCardiocalm8/26/2020Cardiovascular
Limbus ContourLimbus Ai Inc.8/13/2020Radiology
EndoTool IV SystemMonarch Medical Technologies, LLC8/7/20General Hospital
ECG Monitor AppSamsung Electronics Co., Ltd8/4/2020Cardiovascular
EyeArtEyenuk, Inc8/3/20Ophthalmic
AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc7/30/2020Radiology
Fracturedetect (Fx)Imagen Technologies, Inc.7/30/2020Radiology
Caption Interpretation Automated Ejection Fraction SoftwareCaption Health7/22/2020Radiology
AutolignDiorco Co., Ltd.7/21/2020Dental
Ezra Plexo SoftwareEzra Ai, Inc.7/10/2020Radiology
Rapid LVOiSchemaView Inc.7/9/2020Radiology
Contour ProtegeAIMim Software, Inc.7/2/2020Radiology
Inferread Lung CT.AIBeijing Infervision Technology Co.,Ltd.7/2/2020Radiology
Rapid AspectsiSchemaView Inc.6/26/2020Radiology
Lvivo Software ApplicationDia Imaging Analysis Ltd6/23/2020Radiology
Ulab Systems Udesign SoftwareUlab Systems, Inc.6/23/2020Dental
Quantib AI NodeQuantib BV6/15/2020Radiology
EndeavorRxAkili Interactive Labs Inc.6/15/20Neurology
MEDO ARIAMedo.Ai6/11/2020Radiology
uWS-MIShanghai United Imaging Healthcare Co., Ltd.6/11/2020Radiology
Qlab Advanced Quantification SoftwarePhilips Healthcare6/3/2020Radiology
uWS-MRShanghai United Imaging Healthcare Co., Ltd.6/1/2020Radiology
Brainomix 360 E-CTABrainomix Limited5/28/2020Radiology
Dibs (Digital Indirect Bonding System)Orthoselect, LLC4/21/2020Dental
BRUIS Software SuiteMechanodontics, Inc.4/17/2020Dental
Caption GuidanceCaption Health4/16/20Radiology
Curarad-ICHCuracloud Corp.4/13/2020Radiology
Bluestar RxWelldoc, Inc.4/7/2020Clinical Chemistry
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform – go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOSiemens Medical Solutions USA, Inc4/1/2020Radiology
Arterys MICAArterys Inc.3/25/2020Radiology
MammoscreenTherapixel3/25/2020Radiology
SomrystPear Therapeutics, Inc.3/23/2020Neurology
EndoTool IV 1.10Monarch Medical Technologies, LLC3/17/20General Hospital
Syngo.Ct Lung CadSiemens Medical Solutions USA, Inc3/9/2020Radiology
TransparaScreenpoint Medical B.V.3/5/2020Radiology
BroncholabFluidda Inc.3/4/2020Radiology
AccuContourXiamen Manteia Technology Ltd.2/28/2020Radiology
InPen Dose CalculatorCompanion Medical, Inc2/18/20Clinical Chemistry
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.2/10/2020Radiology
Caption GuidanceBay Labs, Inc.2/7/20Radiology
KardiaMobile, KardiaStationAlivecor, Inc.1/24/2020Cardiovascular
Eko Analysis SoftwareEko Devices Inc1/15/20Cardiovascular
Qlab Advanced Quantification SoftwarePhilips Healthcare12/20/2019Radiology
Demetra BDEM-01 DermatoscopeBarco Nv12/13/2019General & Plastic Surgery
Control-IQ TechnologyTandem Diabetes Care, Inc12/13/19Clinical Chemistry
TransparaScreenpoint Medical B.V.12/10/2019Radiology
FFRangioCathworks Ltd12/9/2019Cardiovascular
T3 Platform softwareEtiometry, Inc.12/8/19Cardiovascular
Blood Establishment Computer Software And AccessoriesTerumo BCT, Inc12/3/2019Hematology
Emprint Visualization ApplicationCovidien, LLC12/2/2019Radiology
Hypotension Decision AssistDirected Systems Ltd11/27/2019Cardiovascular
Echogo CoreUltromics Ltd.11/13/2019Radiology
Medip ProMedicalip Co., Ltd11/7/2019Radiology
Welldoc BlueStarWelldoc, Inc.11/4/2019General Hospital
Profound AI Software V2.1Icad Inc.10/4/2019Radiology
Asthma Monitor AM3eResearchTechnology10/3/2019Anesthesiology
RTappSegana, Inc.10/1/2019Radiology
StonecheckerImaging Biometrics, LLC9/26/2019Radiology
SubtleMRSubtle Medical Inc.9/16/2019Radiology
Biovitals Analytics EngineBiofourmis Singapore Pte. Ltd8/15/2019Cardiovascular
HeartfFow FFRct AnalysisHeartflow, Inc.8/15/2019Cardiovascular
Sleepimage SystemMycardio, LLC DBA Sleepimage8/14/2019Anesthesiology
DrowzleResonea, Inc.7/14/2019Anesthesiology
Koios DS For BreastKoios Medical, Inc.7/3/2019Radiology
uWS-CTShanghai United Imaging Healthcare Co., Ltd.6/24/2019Radiology
BD Intelliport SystemBecton, Dickinson, And Company4/30/19General Hospital
uWS-MRShanghai United Imaging Healthcare Co., Ltd.3/22/2019Radiology
KardiaAIAlivecor, Inc.3/11/2019Cardiovascular
DTX Studio designNobel Biocare AB3/1/2019Dental
Myostrain 5.1Myocardial Solutions2/14/2019Radiology
d-Nav SystemHygieia, Inc2/4/19General Hospital
Zoll ECG Analysis SoftwareZoll Manufacturing Corporation1/28/2019Cardiovascular
FFRangio SystemCathworks Ltd12/19/2018Cardiovascular
HipcheckStryker Corp.12/13/2018Radiology
FFRct v2.18Heartflow, Inc.12/6/2018Cardiovascular
Powerlook Tomo Detection V2 SoftwareIcad Inc.12/6/2018Radiology
CAAS Mr SolutionsPie Medical Imaging B.V.12/4/2018Radiology
Ferrismart Analysis SystemResonance Health Analysis Services Pty Ltd11/30/2018Radiology
Orchestrate 3DOrchestrate 3D11/26/2018Dental
TransparaScreenpoint Medical B.V.11/21/2018Radiology
Blood Establishment Computer Software And AccessoriesData Innovations LLC11/8/2018Hematology
uWS-CTShanghai United Imaging Healthcare Co., Ltd.11/7/2018Radiology
uWS-MRShanghai United Imaging Healthcare Co., Ltd.11/7/2018Radiology
ImPACTImPACT Applications, Inc.10/20/2018Neurology
FibriCheckQompium Nv9/28/18Cardiovascular
ECG AppApple Inc.9/11/18Cardiovascular
Irregular Rhythm Notification FeatureApple Inc.9/11/18Cardiovascular
mediCAD 4.0MediCAD Hectec GmbH9/7/2018Radiology
IGTFusionIgi Technologies8/16/2018Radiology
Natural CyclesNatural Cycles Nordic AB8/10/18Obstetrics/Gynecology
Quantitative Total Extensible Imaging (QTxI)AIQ Solutions, Inc.7/23/2018Radiology
Workflow BoxMirada Medical Ltd.7/10/2018Radiology
Blood Establishment Computer Software And AccessoriesMediware Information Systems, Inc.7/3/2018Hematology
Vios Monitoring System™ Model 2050Vios Medical, Inc.6/22/2018Cardiovascular
DreaMed Advisor ProDreaMed Diabetes, Ltd.6/12/18Clinical Chemistry
OsteoDetectImagen Technologies, Inc.5/24/2018Radiology
CAAS WorkstationPie Medical Imaging B.V.5/3/2018Radiology
EncevisAit Austrian Institute Of Technology Gmbh4/19/2018Neurology
IDx-DRIDx, LLC4/11/18Ophthalmic
uWS-MIShanghai United Imaging Healthcare Co., Ltd.4/5/2018Radiology
Simplant 18Dentsply Sirona4/4/2018Radiology
Emprint Ablation Visualization ApplicationCovidien, LLC3/21/2018Radiology
Cerec Ortho SoftwareDentsply Sirona1/11/2018Dental
ULab Systems Treatment Planning SoftwareULab Systems, Inc.1/9/2018Dental
NeuronauteBioserenity12/26/2017Neurology
Sparse Sample Pk Profile And Dosing SoftwareBaxalta US Inc12/14/17Hematology
jFit Surgical PlannerJointVue LLC11/15/2017Radiology
SurgicalPreviewEndo Vantage, LLC11/8/2017Cardiovascular
CSMC Cardiac SuiteCedars-Sinai Medical Center11/3/2017Radiology
LINACwatch, LinacViewQualiformed Sarl10/27/2017Radiology
EndonautTherenva Sas9/21/2017Radiology
ResetPEAR THERAPEUTICS, INC.9/14/17Neurology
Tremoflo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc.9/12/2017Anesthesiology
QuantxQuantitative Insights, Inc7/19/2017Radiology
QuantXQuantitative Insights, Inc7/19/17Radiology
3D Endo SoftwareDentsply Sirona7/17/2017Radiology
ImPACT Quick TestImPACT Applications, Inc.6/21/2017Neurology
Sonosite X-Porte Ultrasound SystemFujifilm Sonosite, Inc.6/12/2017Radiology
EnsoSleepEnsodata, Inc.3/31/2017Neurology
Move Forward 3D Motion Simulation ServiceBiomet Inc.3/31/2017Radiology
My Dose CoachSanofi Inc.3/22/17General Hospital
ImPACTImPACT Applications, Inc.2/23/2017Neurology
CompanionLGCH, INC2/16/17Neurology
Welldoc BlueStar, Welldoc BlueStar RxWelldoc, Inc.1/12/2017General Hospital
Go Dose SystemEli Lilly And Company12/22/2016General Hospital
CipherOx CRI TabletFlashback Technologies, Inc.12/21/16Cardiovascular
CAAS Mr 4D FlowPie Medical Imaging B.V.12/8/2016Radiology
CuattroDRCuattro, LLC10/6/2016Radiology
Blood Establishment Computer Software And AccessoriesMediware Information Systems, Inc.9/30/2016Hematology
ClearRead CTRiverain Technologies, LLC9/9/2016Radiology
FFRct v2.0Heartflow, Inc.8/24/2016Cardiovascular
ResolutionMDCalgary Scientific, Inc8/24/2016Radiology
ImPACT Computerized Neurocognitive Concussion Management AidIMPACT APPLICATIONS, INC.8/22/16Neurology
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFujifilm Sonosite, Inc.8/18/2016Radiology
Kuvia3D4Qimaging, LLC DBA Qmetrics6/23/2016Radiology
EndoSizeTherenva Sas4/12/2016Radiology
Sentinel Cardiology Information Management SystemSpacelabs Healthcare Ltd.4/1/2016Cardiovascular
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEMSPACELABS HEALTHCARE LTD4/1/16Cardiovascular
AdaptivoAurora Technology Development, LLC2/3/2016Radiology
FFRctHeartflow, Inc.1/13/2016Cardiovascular
ImplantMax SoftwareSaturn Imaging Inc.1/12/2016Radiology
syngo VSimSiemens Medical Solutions USA, Inc9/16/2015Radiology
QuickPlanSiris Medical9/11/2015Radiology
CS 3D ImagingTrophy8/19/2015Radiology
Personalized Physiology Analytics Engine SoftwareVgbio, Inc. (DBA Physiq)6/11/2015Cardiovascular
AWAREAmbient Clinical Analytics4/2/2015Cardiovascular
CAAS A-ValvePie Medical Imaging B.V.2/6/2015Radiology
IPACS Medical Image Management SystemVisbion Limited12/12/2014Radiology
HEARTFLOW FFRCTHEARTFLOW11/24/14Cardiovascular
Varia-NCINeurochaos Solutions, Inc.11/19/2014Radiology
Emprint Procedure Planning ApplicationCovidien, LLC9/17/2014Radiology
EndoSizeTherenva Sas7/31/2014Radiology
MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0SMITHS MEDICAL ASD, INC7/25/14General Hospital
Cedars-Sinai Cardiac Suite Nuclear Medicine SoftwareCedars-Sinai Medical Center7/22/2014Radiology
mediCAD ClassicHectec GmbH6/5/2014Radiology
SonoSite Edge Ultrasound SystemFujifilm Sonosite, Inc.12/16/2013Radiology
HepaFat ScanResonance Health Analysis Services Pty Ltd12/13/2013Radiology
M-Vu Breast DensityVucomp, Inc.12/3/2013Radiology
DYONICS PLAN Hip Impingement Planning SystemSmith & Nephew, Inc.10/17/2013Radiology
CorViewMarrek, Inc8/21/2013Radiology
Freestyle Auto-Assist Software Version 2.0 with Model PRT24238-001Abbott Laboratories4/5/2013Clinical Chemistry
CAAS IntraVascularPie Medical Imaging B.V.2/6/2013Radiology
OnQ rtsOncology Systems, Inc.12/28/2012Radiology
EchoSoft(TM)Echometrix LLC9/21/2012Radiology
Blood Establishment Computer Software And AccessoriesMediware Information Systems, Inc.9/19/2012Hematology
VirtuOstO.N. Diagnostics9/13/2012Radiology
Blood Establishment Computer Software And AccessoriesMediware Information Systems, Inc.9/5/2012Hematology
DynaPBV Body SoftwareSiemens Medical Solutions USA, Inc7/30/2012Radiology
NERVEVISION Software Systems3D Imaging Partners Inc.7/26/2012Radiology
Praezis PlusTatramed Spol. S.R.O.5/24/2012Neurology
3mensio WorkstationPie Medical Imaging B.V.4/17/2012Radiology
CAAS A-ValvePie Medical Imaging B.V.1/30/2012Radiology
Swissmeda Dental Planning SystemSwissmeda AG1/25/2012Radiology
Metron-CP/MDEponatech LLC12/20/2011Radiology
syngo Aortic ValveGuide SoftwareSiemens Medical Solutions USA, Inc11/22/2011Radiology
MRI-Q SystemResonance Health Analysis Services Pty Ltd7/28/2011Radiology
CSMC Cardiac Suite-Nuclear Medicine Software Application Model 2010-01Cedars-Sinai Medical Center4/1/2011Radiology
SpineAnalyer Model SAPOCOptasia Medical1/5/2011Radiology
Blood Establishment Computer Software And AccessoriesMediware Information Systems, Inc.11/16/2010Hematology
FulAccess Model 1.0Fulcrum Medical, Inc10/29/2010Radiology
GE EchoPac Model BT10Ge Vingmed Ultrasound As10/5/2010Radiology
Illumina BeadXpress SystemIllumina, Inc.4/28/2010Hematology
Diagnosoft HARP Model 2.06Diagnosoft, Inc.3/11/2010Radiology
Dose Volume Histogram (DVH) EvaluatorDiversilabs, LLC12/16/2009Radiology
PMD ViewerSpencer Technologies10/8/2009Radiology
GE Innova Solid State X-Ray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare8/25/2009Radiology
RayAutoPlan 1.0Raysearch Laboratories AB1/22/2009Radiology
Visage PACS, Version 6.0/CS 3.1Visage Imaging, Inc.12/12/2008Radiology
Standard Imaging IMSure Brachy QA Software, Model 91331Standard Imaging, Inc.11/19/2008Radiology
bp Limbo XL, bp Tango XL, bp Salsa XLDataDancer Medical Systems10/31/2008Cardiovascular
OsDx Hip BMD SystemImaging Therapeutics, Inc.10/16/2008Radiology
VelocityAIS, Velocity AI, VelocityVX, VelocityRT, V-ResponseVelocity Medical Solutions, LLC6/20/2008Radiology
OneTouch Zoom Diabetes Management ProgramLifescan, Inc.6/9/2008Clinical Chemistry
Blood Establishment Computer Software And AccessoriesMak-System5/13/2008Hematology
CMRtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsCardiovascular Imaging Solutions Ltd.2/14/2008Radiology
Modification to: BPCard, Model Z-7000-0700Qrs Diagnostic, LLC1/11/2008Cardiovascular
Blood Establishment Computer Software And AccessoriesMak-System10/26/2007Hematology
Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network10/12/2007General Hospital
MIM 4.1 (SEASTAR)Mimvista Corp.9/26/2007Radiology
Visage PACS/CS, Release Version 5.0Mercury Computer Systems, Inc8/29/2007Radiology
Xebra DICOM Image BrowserHx Technologies, Inc.8/16/2007Radiology
Blood Establishment Computer Software And AccessoriesMak-System5/9/2007Hematology
Blood Establishment Computer Software And AccessoriesPrescott Ideas LLC4/23/2007Hematology
VelocityAISVelocity Medical Solutions, LLC3/1/2007Radiology
AegisSentinelle Medical, Inc.2/9/2007Radiology
ToPACSRadiological Specialists, Inc.1/24/2007Radiology
Visage PACS/CS, Release Version 4.1Mercury Computer Systems, Inc10/27/2006Radiology
Diagnosoft HARPDiagnosoft, Inc.7/28/2006Radiology
PILL PHONEVOCEL3/29/06General Hospital
VISTADENT AT COMPLETE, Model 3.1Dentsply Intl., Inc.11/22/2005Radiology
Hipax Medical Imaging SoftwareSteinhart Medizinsysteme Gmbh9/21/2005Radiology
OPD-Station SoftwareNidek, Inc.8/24/2005Ophthalmic
RADIN, Model V 3.0Sohard Ag1/28/2005Radiology
Vascular Tools 5, Consisting Of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 and Integrated Vascular ToolsMedical Imaging Applications LLC12/16/2004Cardiovascular
MIStar, Model V3.2Apollo Medical Imaging Technology Pty Ltd.12/15/2004Radiology
X-LEONARDOSIEMENS MEDICAL SOLUTIONS USA, INC.11/24/04Radiology
Standard Imaging PIPSpro QA Software SystemStandard Imaging, Inc.11/15/2004Radiology
RSA-CMSMedis Medical Imaging Systems, B.V.10/20/2004Radiology
Ortho-CMSMedis Medical Imaging Systems, B.V.7/27/2004Radiology
ComPACS, Version 1.0Intelligent Images Srl6/22/2004Radiology
MRA-CMSMedis Medical Imaging Systems, B.V.6/8/2004Radiology
Standard Imaging E.IMRT CalculatorStandard Imaging, Inc.5/11/2004Radiology
CT-MassMedis Medical Imaging Systems, B.V.3/2/2004Radiology
OrthopacsEtrauma.Com Corp.2/2/2004Radiology
Modification To Wackers-Liu CQ SoftwareEclipse Systems, Inc.8/25/2003Radiology
Ramsoft Pacs, Model 3.0Ramsoft, Inc.8/11/2003Radiology
Quantitative Vascular Angiography – CMSMedis Medical Imaging Systems, B.V.1/24/2003Radiology
AutoalignCortechs Labs, Inc.7/12/2002Radiology
eFilm Workstation with ModulesEfilm Medical, Inc.4/12/2002Radiology
Opus Spectrum (A Model Of Opus 20), Model 2ndOpusdent Ltd.1/8/2002General & Plastic Surgery
eFilm WorkstationEfilm Medical, Inc.7/31/2001Radiology
QCU Analytical Software PackageMedis Medical Imaging Systems, B.V.7/31/2001Radiology
MRI- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems, B.V.8/30/2000Radiology
Prosolv Echoviewer, Prosolv Echoviewer Se, Prosolv Echoanalyzer, Prosolv Echoserv, Prosolv EchoProblem Solving Concepts, Inc.2/2/2000Radiology
Cardiovascular Measurement System – ViewMedis Medical Imaging Systems, B.V.12/28/1999Radiology
Quantitative Analysis Of Coronary Angiograms (Qca)Medis Medical Imaging Systems, B.V.11/26/1999Radiology
Quantitative Analysis Of Left Ventricular Angiograms (Qlv)Medis Medical Imaging Systems, B.V.11/26/1999Radiology
Itr2000: Internet Teleradiology, Model Release 1.0Inteleradiology, Inc.9/29/1999Radiology
Vox/Base For WindowsJ-Mac System, Inc.10/27/1997Radiology
Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V.8/19/1996Radiology

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