The Healthcare AI Institute / Transparency Registry
Transparency Registry · product code QIH

Automated image processing AI: all 320 FDA clearances

Automated Radiological Image Processing Software. Software that processes radiological images automatically — enhancement, measurement, reconstruction — without a clinician initiating each step. This list is generated from openFDA public records and refreshes automatically every week — bookmark it and it stays current.

DeviceApplicantDecision date
Prostate CoreLucida Medical, Ltd.2026-08-10
mdprostateMediaire GmbH2026-08-07
RealGUIDE3DIEMME SRL2026-08-04
AffinityHermes Medical Solutions AB2026-07-31
cmAngio® V2.0Curemetrix, Inc.2026-07-30
Cleerly PlaqueCleerly, Inc.2026-07-29
SwiftMRAirs Medical, Inc.2026-07-24
DIANAROPCA ApS2026-07-24
VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.2026-07-23
Hi-D Imaging 4TAVRHi-D Imaging AG2026-07-20
SkeletonPlannerUPlanner B.V. - Presurgeo2026-07-15
InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.2026-07-07
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd.2026-06-29
ADAS 3DAdas3D Medical S.L.2026-06-29
syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.2026-06-25
CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S2026-06-22
Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation2026-06-18
LungMapsSiemens Healthineers AG2026-06-15
WatchMate SoftwareAnumana, Inc.2026-06-15
MediAI-OACrescom Co., Ltd.2026-06-15
Brainomix 360 HyperdensityBrainomix Limited2026-06-12
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical2026-06-11
DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.2026-06-04
OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.2026-05-29
ANDI 2.2Imeka Solutions, Inc.2026-05-28
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc.2026-05-22
MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.2026-05-21
BACDeepHealth, Inc.2026-05-21
Neurophet SCALE PETNeurophet., Inc.2026-05-15
Neurophet AQUANeurophet., Inc.2026-05-15
UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)2026-05-15
SubtleHD-CT (1.x)Subtle Medical, Inc.2026-05-15
MorphBeauBrain Healthcare, Inc.2026-05-13
Synapse 3D Base Tools (V7.2)Fujifilm Corporation2026-04-30
syngo Application SoftwareSiemens Medical Solutions USA, Inc.2026-04-29
DS Core CBCT AnatomyDentsply Sirona2026-04-23
uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.2026-04-22
FolliscanMim Fertility2026-04-20
Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC2026-04-14
Overjet Iris Intelligent Imaging SystemOverjet, Inc.2026-04-10
Relu CloudRelu BV2026-04-10
syngo Dynamics (VA41F)Siemens Healthcare GmbH2026-04-10
CoLumbo C-SpineSmart Soft Healthcare AD2026-04-01
AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.2026-03-30
SwiftMRAirs Medical, Inc.2026-03-26
EchoNavigator R5.0Philips Medical Systems Nederland B.V.2026-03-17
Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated2026-03-16
InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.2026-03-13
VELYS™ Hip NavigationDepuy Ireland UC2026-03-06
CEPHX3DOrca Dental AI , Ltd.2026-03-05
Clarius Ejection Fraction AIClarius Mobile Health Corp.2026-03-02
Ligence HeartLigence Uab2026-02-27
AI Platform 2.2 (AIP002)Exo Imaging2026-02-24
AI4CMR v2.0Ai4medimaging Medical Solutions S.A.2026-02-11
MI View&GOSiemens Medical Solutions USA, Inc.2026-02-10
Neurophet AQUA AD PlusNeurophet., Inc.2026-01-29
Surgical Reality ViewerMedicalvr B.V.2026-01-29
AV VascularPhilips Medical Systems Nederland B.V.2026-01-22
AI-Rad Companion Brain MRSiemens Healthcare GmbH2026-01-22
Imagine® Enterprise SuiteSoftlink International Private Limited2026-01-16
TruSPECT Processing StationSpectrum Dynamics Medical, Ltd.2025-12-30
PeekMed webPeek Health, S.A.2025-12-22
AlzevitaTOPIA MEDTECH LIMITED2025-12-19
AI-CVDHeartLung Corporation2025-12-19
PVAD IQ SoftwareUltrasight , Ltd.2025-12-18
MediAI-BACrescom Co., Ltd.2025-12-18
Neosoma Brain MetsNeosoma, Inc.2025-12-17
IRISegIntuitive Surgical, Inc.2025-12-16
Overjet CBCT AssistOverjet, Inc.2025-12-05
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical2025-12-02
AutoDensityEos Imaging2025-11-14
PeekMed webPeek Health, S.A.2025-11-12
3mensio WorkstationPie Medical Imaging BV2025-11-03
AiORTA - PlanViTAA Medical Solutions, Inc.2025-10-30
cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.2025-10-27
Syngo Carbon Clinicals (VA41)Siemens Healthineers AG2025-10-24
TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.2025-10-23
ANDI 2.0Imeka Solutions, Inc.2025-10-22
brAIn™ Shoulder PositioningAvatar Medical2025-10-20
AIAS CephalonMetamorphosis GmbH2025-10-07
BlineSlideDeep Breathe, Inc.2025-10-06
SMART PCFDDisior, Ltd.2025-09-29
Ligence HeartLigence Uab2025-09-26
Brain WMHQuantib B.V.2025-09-25
Rapid Aortic MeasurementsIschemaview, Inc.2025-09-23
SwiftSight-BrainAirs Medical, Inc.2025-09-23
Axial3D InsightAxial Medical Printing Limited2025-09-18
InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.2025-09-15
AngioWaveNetAngiowave Imaging, Inc.2025-09-10
Segmentron ViewerDGNCT, LLC2025-09-09
Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte. , Ltd.2025-09-04
Tempus PixelArterys, Inc.2025-09-03
PRAEVAorta®2Nurea2025-08-29
VistaSoft 4.0 and VisionX 4.0Durr Dental SE2025-08-27
MammoScreen BDTherapixel2025-08-22
GBrain MRIGalileo Cds, Inc.2025-08-22
Salix Coronary Plaque (V1.0.0)Artrya Limited2025-08-20
VEA Align; spineEOSEos Imaging2025-08-15
DS Core DiagnosisDentsply Sirona, Inc.2025-08-12
UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)2025-08-07
Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB2025-07-30
EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics2025-07-16
PeekMed webPeek Health, S.A.2025-07-14
TumorSight VizSimBioSys, Inc.2025-07-08
syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.2025-07-03
Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health2025-07-01
PIUR tUS insidePiur Imaging GmbH2025-06-30
EchoConfidence (USA)Mycardium AI Limited2025-06-30
Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation2025-06-30
Brainlab 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 Brainlab AG2025-06-13
Viz Subdural+, Viz SUBDURAL PLUSViz. Ai, Inc.2025-06-10
Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc.2025-06-06
BrightHeart View ClassifierBrightheart2025-06-05
TraumaCad Neo (1.1)Brainlab , Ltd.2025-06-04
AudaxCeph Cephalogram Analysis SoftwareAudax D.O.O.2025-05-30
Opulus™ Lymphoma PrecisionRoche Molecular Systems, Inc.2025-05-30
Rapid MLSIschemaview, Inc.2025-05-28
CoLumboXSmart Soft Healthcare AD2025-05-28
Second Opinion® 3DPearl, Inc.2025-05-23
Clever OneEwoosoft Co., Ltd.2025-05-23
Synapse 3D Base Tools (V7.0)Fujifilm Corporation2025-05-21
Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.2025-05-14
Second Opinion® BLEPearl, Inc.2025-05-09
Clarius Median Nerve AIClarius Mobile Health Corp.2025-05-08
BrightHeart View ClassifierBrightheart2025-05-07
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation2025-04-30
Clarius Prostate AIClarius Mobile Health Corp.2025-04-16
LARALABLaralab GmbH2025-04-16
GBrain MRIGalileo Cds, Inc.2025-04-11
cmAngio® (V1.6)Curemetrix, Inc.2025-04-10
DeepFoqus (DeepFoqus-Accelerate)Foqus Technologies, Inc.2025-04-04
syngo Dynamics (Version VA41D)Siemens Healthcare GmbH2025-04-03
Hi-D Imaging 4TAVRHi-D Imaging AG2025-04-02
TribusConnectTribusmed Beheer BV2025-03-31
Salix CentralArtrya Limited2025-03-27
Vent Creativity Knee v1.0 (Hermes)Vent Creativity2025-03-20
PeekMed webPeek Health, S.A.2025-03-19
AVIEWCoreline Soft Co., Ltd.2025-03-19
LVivo Software ApplicationDia Imaging Analysis, Ltd.2025-03-17
Cleerly LABS (v2.0)Cleerly, Inc.2025-03-07
LVivo SeamlessDia Imaging Analysis, Ltd.2025-03-06
Ceevra Reveal 3+Ceevra, Inc.2025-03-04
LVivo Software ApplicationDia Imaging Analysis, Ltd.2025-03-03
MyomicsPhantomics, Inc.2025-02-28
Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics , Ltd.2025-02-26
ScanDiags Ortho L-Spine MR-QScandiags AG2025-02-21
AVIEW CACCoreline Soft Co., Ltd.2025-02-14
SubtleHD (1.x)Subtle Medical, Inc.2025-02-12
Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC2025-02-10
BoneMetrics (US)Gleamer Sas2025-02-05
TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.2025-01-23
Rapid Neuro3DIschemaview, Inc.2025-01-22
Ortho AIOrtho Ai, LLC2025-01-02
Ezra FlashEzra Ai, Inc.2025-01-02
Saige-Density (2.5.0)DeepHealth, Inc.2024-12-19
OrthoNext Platform SystemOrthofix Srl2024-12-19
MSKaiMskai2024-12-16
IRISegIntuitive Surgical, Inc.2024-12-10
DrAid™ for Liver SegmentationVinbrain Joint Stock Company2024-12-06
CDM InsightsOxford Brain Diagnostics, Ltd.2024-12-06
Sonix HealthOntact Health Co., Ltd.2024-11-27
BriefCase-QuantificationAidoc Medical , Ltd.2024-11-22
Strain AI (SAI001)Exo, Inc.2024-11-20
TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.2024-11-05
RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.2024-10-30
Neurophet AQUA (V3.1)Neurophet., Inc.2024-10-25
TumorSight VizSimBioSys, Inc.2024-10-25
cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.2024-10-15
AutoChamberHeartLung Corporation2024-10-10
EchoMeasureIcardio.Ai2024-10-10
LVivo Software ApplicationDia Imaging Analysis, Ltd.2024-10-04
MammoScreen BDTherapixel2024-10-02
LungVisionBodyvision Medical , Ltd.2024-10-01
PIUR tUS InfinityPiur Imaging GmbH2024-09-20
Constellation (CON-001)Q Bio, Inc.2024-09-12
LumiNE US; LumiAugmedit B.V.2024-09-10
ADAS 3DAdas3D Medical S.L.2024-09-09
Overjet Image Enhancement AssistOverjet, Inc.2024-09-09
uAI PortalShanghai United Imaging Intelligence Co., Ltd.2024-09-06
Imbio PHA (4.0.0)Imbio, Inc.2024-08-30
syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.2024-08-30
MI View&GOSiemens Medical Solutions USA, Inc.2024-08-30
Overjet Charting AssistOverjet, Inc.2024-08-27
NeuroQuantCortechs Labs, Inc.2024-08-22
qCT LN QuantQure.Ai Technologies2024-08-16
CoLumboSmart Soft Healthcare2024-08-15
OptimMRI (v2)Rebrain, Sas2024-08-12
i2ContourMrimath, LLC2024-08-08
AI Platform 2.0 (AIP002)Exo Imaging2024-08-05
RUSHutom, Inc.2024-07-12
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical2024-07-12
SubtleSYNTH (1.x)Subtle Medical, Inc.2024-07-11
SMART Bun-Yo-Matic X-RayDisior, Ltd.2024-07-02
VEA Align; spineEOSEos Imaging2024-06-25
Medihub ProstateJLK, Inc.2024-06-21
SMART Bun-Yo-Matic CTDisior, Ltd.2024-06-20
SIS SystemSurgical Information Sciences, Inc.2024-06-14
Relu CreatorRelu BV2024-06-13
Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging2024-06-07
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.2024-06-07
LVivo IQSDia Imaging Analysis, Ltd.2024-05-24
uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.2024-05-17
BriefCase-QuantificationAidoc Medical , Ltd.2024-05-15
InVision Precision LVEF (LVEF)InVision Medical Technology Corporation2024-04-25
uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.2024-04-17
Preview ShoulderGenesis Software Innovations2024-04-04
Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai2024-04-01
AVIEW CACCoreline Soft Co., Ltd.2024-03-29
iCAS-LVHighrad , Ltd.2024-03-01
BoneMRIMriguidance B.V.2024-03-01
inHEART ModelsInheart, Sas2024-02-29
CT CardiomegalyInnolitics, LLC2024-02-28
Overjet Charting AssistOverjet, Inc.2024-02-23
Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc.2024-02-05
NemoScanSoftware Nemotec S.L.2024-01-18
Rapid (6.0)Ischemaview, Inc.2024-01-16
DASI Dimensions (V1.0)Dasi Simulations2024-01-08
VEA AlignEos Imaging2024-01-05
TumorSight VizSimBioSys, Inc.2023-12-26
iQ-solutionsSydney Neuroimaging Analysis Centre Pty, Ltd.2023-12-18
QP-Brain®Quibim S.L.2023-12-13
Transpara Density 1.0.0Screenpoint Medical B.V.2023-12-11
BonelogicDisior, Ltd.2023-12-08
Adravision PerioAdra Corporation2023-12-05
Ceevra Reveal 3+Ceevra, Inc.2023-12-05
Syngo Carbon ClinicalsSiemens Healthcare GmbH2023-12-01
syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.2023-11-28
AI Platform (AIP001)Exo, Inc.2023-11-17
Axial3D InsightAxial Medical Printing Limited2023-11-15
Clarius Bladder AIClarius Mobile Health Corp.2023-11-13
BriefCase-QuantificationAidoc Medical , Ltd.2023-11-13
BriefCase-QuantificationAidoc Medical , Ltd.2023-11-08
aprevo® Digital SegmentationCarlsmed, Inc.2023-11-03
AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.2023-10-23
Sonix HealthOntact Health Co., Ltd.2023-10-20
cmAngio® V1.0Curemetrix, Inc.2023-10-05
VUNO Med-DeepBrainVuno, Inc.2023-10-04
HipCheckStryker Corp.2023-09-29
qXR-CTRQure.Ai Technologies2023-09-22
DeepXrayAlpha Intelligence Manifolds, Inc.2023-09-08
ANDIImeka Solutions, Inc.2023-07-25
OptimMRIRebrain, Sas2023-07-21
uOmnispaceShanghai United Imaging Healthcare Co., Ltd.2023-07-20
Ez3D-i /E3Ewoosoft Co., Ltd.2023-07-14
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 AG2023-07-14
Spine CAMP™ (1.1)Medical Metrics, Inc.2023-07-07
Axial3D InsightAxial Medical Printing Limited2023-07-03
Bladder AI (AIBV01)Exo, Inc.2023-06-22
IB Lab LAMAIb Lab GmbH2023-06-16
DeepCatchMedical IP Co., Ltd.2023-06-16
FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV2023-06-06
SIS SystemSurgical Information Sciences, Inc.2023-05-02
Ceevra Reveal 3Ceevra, Inc.2023-04-25
ViewFinder Software Version 1.1Elaitra, Ltd.2023-04-21
CerebralGo PlusYukun (Beijing) Technology Co., Ltd.2023-04-13
Formus HipFormus Labs, Ltd.2023-03-31
RadioLens v1.0Synapsica2023-03-28
MPXA-2000Medipixel, Inc.2023-03-22
BoneMRI v1.6Mriguidance B.V.2023-02-22
Videa Perio AssistVideahealth, Inc.2023-02-06
LVivo IQSDia Imaging Analysis, Ltd.2023-02-01
Rapid RV/LVIschemaview, Inc.2023-02-01
Clarius AIClarius Mobile Health Corp.2023-01-23
AVIEWCoreline Soft Co., Ltd.2022-12-23
BrainInsightHyperfine, Inc.2022-12-16
Saige-DensityDeepHealth, Inc.2022-12-16
SIS System (Version 5.6.0)Surgical Information Sciences, Inc.2022-11-21
BoneMRI v1.4Mrlguidance B.V.2022-11-16
Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.2022-11-14
Spine CAMP™Medical Metrics, Inc.2022-10-18
QIR SuiteCasis Cardiac Simulation & Imaging Software2022-09-30
NS-HGlioNeosoma, Inc.2022-09-27
Viz RV/LVViz. Ai, Inc.2022-08-29
MI View&GOSiemens Medical Solutions USA, Inc.2022-08-19
ClearPoint Maestro Brain ModelClearPoint Neuro, Inc.2022-08-08
Customize3D-Side S.A.2022-08-03
cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.2022-07-28
EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics2022-07-22
Libby Echo:PrioDyad Medical, Inc.2022-07-20
BrainInsightHyperfine, Inc.2022-07-19
CoLumboSmart Soft Healthcare AD2022-06-23
AI-Rad Companion Brain MRSiemens Healthcare GmbH2022-04-15
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.2022-04-04
Customize3D-Side S.A.2022-03-16
Arterys MICAArterys, Inc.2022-03-14
Caption Interpretation Automated Ejection Fraction SoftwareCaption Health2022-01-19
Follicle ClarityCycle Clarity2022-01-19
TOMTEC-ARENATomtec Imaging Systems GmbH2022-01-06
BoneMRIMriguidance B.V.2021-12-22
qXR-BTQure.Ai Technologies2021-12-21
EchoGo Core (2.0)Ultromics Limited2021-12-20
LVivo SeamlessDia Imaging Analysis, Ltd.2021-12-09
OnQ NeuroCortechs Labs, Inc.2021-11-19
Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC2021-10-29
ClariSIGMAMClaripi, Inc.2021-09-10
AmCAD-UTAmcad Biomed Corporation2021-09-08
breastscape v1.0Olea Medical2021-08-02
qER-QuantQure.Ai Technologies2021-07-30
Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai2021-07-27
Change Healthcare Anatomical AIChange Healthcare Canada Company2021-07-20
PowerLook Density Assessment V4.0Icad, Inc.2021-07-12
syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.2021-06-10
MEDO-ThyroidMedo DX Pte. , Ltd.2021-04-23
Preview ShoulderGenesis Software Innovations2021-04-21
Imbio RV/LV SoftwareImbio, LLC2021-03-09
LVivo Software ApplicationDia Imaging Analysis, Ltd.2021-02-05
Visage Breast DensityVisage Imaging GmbH2021-01-29
syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.2020-11-18
WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.2020-10-30
LVivo SeamlessDia Imaging Analysis, Ltd.2020-09-29
AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.2020-07-30
Caption Interpretation Automated Ejection Fraction SoftwareCaption Health2020-07-22
Ezra Plexo SoftwareEzra Ai, Inc.2020-07-10
LVivo Software ApplicationDia Imaging Analysis, Ltd.2020-06-23
MEDO ARIAMedo.Ai2020-06-11
QLAB Advanced Quantification SoftwarePhilips Health Care2020-06-03
uWS-MRShanghai United Imaging Healthcare Co., Ltd.2020-06-01
Arterys MICAArterys, Inc.2020-03-25
QLAB Advanced Quantification SoftwarePhilips Health Care2019-12-20
EchoGo CoreUltromics, Ltd.2019-11-13

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