AI devices with FDA product code QIH — Automated Radiological Image Processing Software
Product code QIH (“Automated Radiological Image Processing Software” in openFDA) covers 305 devices on the FDA AI-enabled list, from 209 companies. Most are reviewed by the Radiology panel (305). The most recent decision was Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) on June 29, 2026.
305AI devices
180Companies
2019First decision
2026-06-29Latest decision
Trend: devices per year
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Top companies
All 305 devices, newest first
- Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd. · Radiology
- ADAS 3DAdas3D Medical S.L. · Radiology
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S · Radiology
- Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · Radiology
- MediAI-OACrescom Co., Ltd. · Radiology
- LungMapsSiemens Healthineers AG · Radiology
- WatchMate SoftwareAnumana, Inc. · Radiology
- Brainomix 360 HyperdensityBrainomix Limited · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd. · Radiology
- OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc. · Radiology
- ANDI 2.2Imeka Solutions, Inc. · Radiology
- Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc. · Radiology
- BACDeepHealth, Inc. · Radiology
- MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S. · Radiology
- Neurophet SCALE PETNeurophet., Inc. · Radiology
- SubtleHD-CT (1.x)Subtle Medical, Inc. · Radiology
- Neurophet AQUANeurophet., Inc. · Radiology
- UNiD Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) · Radiology
- MorphBeauBrain Healthcare, Inc. · Radiology
- Synapse 3D Base Tools (V7.2)Fujifilm Corporation · Radiology
- syngo Application SoftwareSiemens Medical Solutions USA, Inc. · Radiology
- DS Core CBCT AnatomyDentsply Sirona · Radiology
- uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- FolliscanMim Fertility · Radiology
- Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC · Radiology
- Relu CloudRelu BV · Radiology
- syngo Dynamics (VA41F)Siemens Healthcare GmbH · Radiology
- Overjet Iris Intelligent Imaging SystemOverjet, Inc. · Radiology
- CoLumbo C-SpineSmart Soft Healthcare AD · Radiology
- AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · Radiology
- SwiftMRAirs Medical, Inc. · Radiology
- EchoNavigator R5.0Philips Medical Systems Nederland B.V. · Radiology
- Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated · Radiology
- InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd. · Radiology
- VELYS Hip NavigationDepuy Ireland UC · Radiology
- CEPHX3DOrca Dental AI , Ltd. · Radiology
- Clarius Ejection Fraction AIClarius Mobile Health Corp. · Radiology
- Ligence HeartLigence Uab · Radiology
- AI Platform 2.2 (AIP002)Exo Imaging · Radiology
- AI4CMR v2.0Ai4medimaging Medical Solutions S.A. · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
- Surgical Reality ViewerMedicalvr B.V. · Radiology
- Neurophet AQUA AD PlusNeurophet., Inc. · Radiology
- AV VascularPhilips Medical Systems Nederland B.V. · Radiology
- AI-Rad Companion Brain MRSiemens Healthcare GmbH · Radiology
- Imagine® Enterprise SuiteSoftlink International Private Limited · Radiology
- TruSPECT Processing StationSpectrum Dynamics Medical, Ltd. · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- AlzevitaTOPIA MEDTECH LIMITED · Radiology
- AI-CVDHeartLung Corporation · Radiology
- MediAI-BACrescom Co., Ltd. · Radiology
- PVAD IQ SoftwareUltrasight , Ltd. · Radiology
- Neosoma Brain MetsNeosoma, Inc. · Radiology
- IRISegIntuitive Surgical, Inc. · Radiology
- Overjet CBCT AssistOverjet, Inc. · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- AutoDensityEos Imaging · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- 3mensio WorkstationPie Medical Imaging BV · Radiology
- AiORTA - PlanViTAA Medical Solutions, Inc. · Radiology
- cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc. · Radiology
- Syngo Carbon Clinicals (VA41)Siemens Healthineers AG · Radiology
- TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · Radiology
- ANDI 2.0Imeka Solutions, Inc. · Radiology
- brAIn Shoulder PositioningAvatar Medical · Radiology
- AIAS CephalonMetamorphosis GmbH · Radiology
- BlineSlideDeep Breathe, Inc. · Radiology
- SMART PCFDDisior Ltd · Radiology
- Ligence HeartLigence, UAB · Radiology
- Brain WMHQuantib BV · Radiology
- SwiftSight-BrainAIRS Medical Inc. · Radiology
- Rapid Aortic MeasurementsiSchemaView, Inc. · Radiology
- Axial3D InsightAxial Medical Printing Limited · Radiology
- InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · Radiology
- AngioWaveNetAngiowave Imaging, Inc. · Radiology
- Segmentron ViewerDGNCT, LLC · Radiology
- Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte. Ltd. · Radiology
- Tempus PixelArterys, Inc. · Radiology
- PRAEVAorta®2Nurea · Radiology
- GBrain MRIGalileo CDS, Inc · Radiology
- MammoScreen BDTherapixel · Radiology
- Salix Coronary Plaque (V1.0.0)Artrya Limited · Radiology
- VEA Align; spineEOSEOS imaging · Radiology
- DS Core DiagnosisDentsply Sirona Inc. · Radiology
- UNiD Spine AnalyzerMedicrea International S.A.S. (Medtronic) · Radiology
- Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB · Radiology
- EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- TumorSight VizSimBioSys, Inc. · Radiology
- syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health · Radiology
- PIUR tUS insidePIUR Imaging GmbH · Radiology
- Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation · Radiology
- EchoConfidence (USA)Mycardium AI Limited · Radiology
- 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 BOLD MRI Mapping (1.0)Brainlab AG · Radiology
- Viz Subdural+, Viz SUBDURAL PLUSViz.ai, Inc. · Radiology
- Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc. · Radiology
- BrightHeart View ClassifierBrightHeart · Radiology
- TraumaCad Neo (1.1)Brainlab Ltd. · Radiology
- AudaxCeph Cephalogram Analysis SoftwareAudax d.o.o. · Radiology
- Opulus Lymphoma PrecisionRoche Molecular Systems, Inc. · Radiology
- CoLumboXSmart Soft Healthcare AD · Radiology
- Rapid MLSiSchemaview Inc. · Radiology
- Clever OneEwoosoft Co., Ltd · Radiology
- Second Opinion® 3DPearl, Inc. · Radiology
- Synapse 3D Base Tools (V7.0)FUJIFILM Corporation · Radiology
- Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Second Opinion® BLEPearl Inc. · Radiology
- Clarius Median Nerve AIClarius Mobile Health Corp. · Radiology
- BrightHeart View ClassifierBrightHeart · Radiology
- UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation · Radiology
- LARALABLARALAB GmbH · Radiology
- Clarius Prostate AIClarius Mobile Health Corp. · Radiology
- GBrain MRIGalileo CDS, Inc · Radiology
- cmAngio® (V1.6)CureMetrix, Inc. · Radiology
- DeepFoqus (DeepFoqus-Accelerate)Foqus Technologies Inc. · Radiology
- syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · Radiology
- Hi-D Imaging 4TAVRHi-D Imaging AG · Radiology
- TribusConnectTribusMed Beheer BV · Radiology
- Salix CentralArtrya Limited · Radiology
- Vent Creativity Knee v1.0 (Hermes)Vent Creativity · Radiology
- AVIEWCoreline Soft Co., Ltd. · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd. · Radiology
- Cleerly LABS (v2.0)Cleerly, Inc. · Radiology
- LVivo SeamlessDiA Imaging Analysis Ltd. · Radiology
- Ceevra Reveal 3+Ceevra, Inc. · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd. · Radiology
- MyomicsPhantomics Inc. · Radiology
- Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics Ltd. · Radiology
- ScanDiags Ortho L-Spine MR-QScanDiags AG · Radiology
- AVIEW CACCoreline Soft Co., Ltd. · Radiology
- SubtleHD (1.x)Subtle Medical, Inc. · Radiology
- Ultrasound Workspace (UWS 6.0)Philips Ultrasound LLC · Radiology
- BoneMetrics (US)Gleamer SAS · Radiology
- TeraRecon Aorta.CT (1.1.0)TeraRecon, Inc. · Radiology
- Rapid Neuro3DiSchemaView, Inc. · Radiology
- Ortho AIOrtho AI LLC · Radiology
- Ezra FlashEzra AI, Inc. · Radiology
- Saige-Density (2.5.0)DeepHealth, Inc · Radiology
- OrthoNext Platform SystemOrthofix Srl · Radiology
- MSKaiMSKai · Radiology
- IRISegIntuitive Surgical Inc. · Radiology
- DrAid for Liver SegmentationVinBrain Joint Stock Company · Radiology
- CDM InsightsOxford Brain Diagnostics Ltd · Radiology
- Sonix HealthOntact Health Co., Ltd · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- Strain AI (SAI001)Exo Inc · Radiology
- TeraRecon Cardiac.Chambers.MR (1.0.0)TeraRecon,Inc. · Radiology
- RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic Inc. · Radiology
- TumorSight VizSimBioSys, Inc. · Radiology
- Neurophet AQUA (V3.1)Neurophet, Inc. · Radiology
- cvi42 Software ApplicationCircle Cardiovascular Imaging Inc. · Radiology
- EchoMeasureiCardio.ai · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd. · Radiology
- MammoScreen BDTherapixel · Radiology
- LungVisionBodyVision Medical Ltd. · Radiology
- PIUR tUS InfinityPIUR Imaging GmbH · Radiology
- Constellation (CON-001)Q Bio, Inc. · Radiology
- LumiNE US; LumiAugmedit B.V. · Radiology
- ADAS 3DAdas3D Medical S.L · Radiology
- Overjet Image Enhancement AssistOverjet Inc · Radiology
- uAI PortalShanghai United Imaging Intelligence Co., Ltd. · Radiology
- Imbio PHA (4.0.0)Imbio, Inc · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
- syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- Overjet Charting AssistOverjet, Inc · Radiology
- NeuroQuantCorTechs Labs, Inc. · Radiology
- qCT LN QuantQure.ai Technologies · Radiology
- CoLumboSmart Soft Healthcare · Radiology
- OptimMRI (v2)Rebrain, SAS · Radiology
- i2ContourMRIMath LLC · Radiology
- AI Platform 2.0 (AIP002)Exo Imaging · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- RUSHutom Inc. · Radiology
- SubtleSYNTH (1.x)Subtle Medical, Inc. · Radiology
- SMART Bun-Yo-Matic X-RayDisior Ltd · Radiology
- VEA Align; spineEOSEOS imaging · Radiology
- Medihub ProstateJLK Inc. · Radiology
- SMART Bun-Yo-Matic CTDisior Ltd · Radiology
- SIS SystemSurgical Information Sciences, Inc. · Radiology
- Relu CreatorRelu BV · Radiology
- Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging · Radiology
- EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.AI Co., Ltd. · Radiology
- LVivo IQSDiA Imaging Analysis Ltd. · Radiology
- uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd. · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- InVision Precision LVEF (LVEF)InVision Medical Technology Corporation · Radiology
- uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Preview ShoulderGenesis Software Innovations · Radiology
- Us2.v2Eko.ai Pte. Ltd d/b/a Us2.ai · Radiology
- AVIEW CACCoreline Soft Co., Ltd. · Radiology
- BoneMRIMRIguidance B.V · Radiology
- iCAS-LVHighRAD Ltd. · Radiology
- inHEART ModelsinHEART, SAS · Radiology
- CT CardiomegalyInnolitics, LLC · Radiology
- Overjet Charting AssistOverjet, Inc · Radiology
- Viz HDS, Viz Volume Plus, Viz ICH+Viz.ai, Inc. · Radiology
- NemoScanSoftware Nemotec S.L. · Radiology
- Rapid (6.0)iSchemaView, Inc. · Radiology
- DASI Dimensions (V1.0)DASI Simulations · Radiology
- VEA AlignEOS imaging · Radiology
- TumorSight VizSimBioSys, Inc. · Radiology
- iQ-solutionsSydney Neuroimaging Analysis Centre Pty Ltd · Radiology
- QP-Brain®Quibim S.L. · Radiology
- Transpara Density 1.0.0Screenpoint Medical B.V. · Radiology
- Adravision PerioAdra Corporation · Radiology
- Ceevra Reveal 3+Ceevra, Inc. · Radiology
- Syngo Carbon ClinicalsSiemens Healthcare GmbH · Radiology
- syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- AI Platform (AIP001)Exo Inc · Radiology
- Axial3D InsightAxial Medical Printing Limited · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- Clarius Bladder AIClarius Mobile Health Corp. · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- aprevo® Digital SegmentationCarlsmed, Inc. · Radiology
- AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A. · Radiology
- Sonix HealthOntact Health Co., Ltd. · Radiology
- cmAngio® V1.0CureMetrix, Inc. · Radiology
- VUNO Med-DeepBrainVUNO Inc. · Radiology
- HipCheckStryker Corp. · Radiology
- qXR-CTRQure.ai Technologies · Radiology
- DeepXrayAlpha Intelligence Manifolds, Inc. · Radiology
- ANDIImeka Solutions, Inc. · Radiology
- OptimMRIRebrAIn, SAS · Radiology
- uOmnispaceShanghai United Imaging Healthcare Co., Ltd · Radiology
- Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)Brainlab AG · Radiology
- Ez3D-i /E3Ewoosoft Co., Ltd · Radiology
- Spine CAMP (1.1)Medical Metrics, Inc. · Radiology
- Axial3D InsightAxial Medical Printing Limited · Radiology
- Bladder AI (AIBV01)Exo Inc · Radiology
- DeepCatchMEDICALIP Co., Ltd · Radiology
- IB Lab LAMAIB Lab GmbH · Radiology
- FEops HEARTguideTM, FEops HEARTguideTM ALPACAFEops nv · Radiology
- SIS SystemSurgical Information Sciences, Inc. · Radiology
- Ceevra Reveal 3Ceevra, Inc. · Radiology
- ViewFinder Software Version 1.1Elaitra Ltd · Radiology
- CerebralGo PlusYukun (Beijing) Technology Co., Ltd · Radiology
- Formus HipFormus Labs, Ltd · Radiology
- RadioLens v1.0Synapsica · Radiology
- MPXA-2000Medipixel, Inc. · Radiology
- BoneMRI v1.6MRIguidance B.V. · Radiology
- Videa Perio AssistVideaHealth, Inc. · Radiology
- LVivo IQSDiA Imaging Analysis Ltd · Radiology
- Rapid RV/LViSchema View Inc. · Radiology
- Clarius AIClarius Mobile Health Corp. · Radiology
- AVIEWCoreline Soft Co.,Ltd. · Radiology
- BrainInsightHyperfine, Inc. · Radiology
- Saige-DensityDeepHealth, Inc. · Radiology
- SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · Radiology
- BoneMRI v1.4MRlguidance B.V. · Radiology
- Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. · Radiology
- Spine CAMPMedical Metrics, Inc. · Radiology
- QIR SuiteCASIS Cardiac Simulation & Imaging Software · Radiology
- NS-HGlioNeosoma Inc. · Radiology
- Viz RV/LVViz.ai, Inc. · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
- ClearPoint Maestro Brain ModelClearPoint Neuro, Inc. · Radiology
- Customize3D-Side SA · Radiology
- cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging Inc · Radiology
- EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Libby Echo:PrioDyad Medical, Inc · Radiology
- BrainInsightHyperfine, Inc. · Radiology
- CoLumboSmart Soft Healthcare AD · Radiology
- AI-Rad Companion Brain MRSiemens Healthcare GmBh · Radiology
- EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune. AI Co., Ltd. · Radiology
- Customize3D-Side SA · Radiology
- Arterys MICAArterys Inc. · Radiology
- Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · Radiology
- Follicle ClarityCycle Clarity · Radiology
- TOMTEC-ARENATOMTEC Imaging Systems GmbH · Radiology
- BoneMRIMRIguidance B.V · Radiology
- qXR-BTQure.ai Technologies · Radiology
- EchoGo Core (2.0)Ultromics Limited · Radiology
- LVivo SeamlessDiA Imaging Analysis Ltd · Radiology
- OnQ NeuroCorTechs Labs, Inc · Radiology
- Critical Care Suite with Endotracheal Tube Positing AI algorithmGE Medical Systems, LLC · Radiology
- ClariSIGMAMClariPi Inc. · Radiology
- AmCAD-UTAmCad BioMed Corporation · Radiology
- breastscape v1.0Olea Medical · Radiology
- qER-QuantQure.ai Technologies · Radiology
- Us2.v1eko.ai Pte. Ltd. d/b/a Us2.ai · Radiology
- Change Healthcare Anatomical AIChange Healthcare Canada Company · Radiology
- PowerLook Density Assessment V4.0iCAD, Inc. · Radiology
- syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- MEDO-ThyroidMEDO DX Pte. Ltd. · Radiology
- Preview ShoulderGenesis Software Innovations · Radiology
- Imbio RV/LV SoftwareImbio, LLC · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd · Radiology
- Visage Breast DensityVisage Imaging GmbH · Radiology
- syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- WRDensity by Whiterabbit.aiWhiterabbit.ai Inc. · Radiology
- LVivo SeamlessDiA Imaging Analysis Ltd · Radiology
- AI-Rad Companion Prostate MRSiemens Medical Solutions USA Inc. · Radiology
- Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · Radiology
- Ezra Plexo SoftwareEzra AI Inc. · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd · Radiology
- MEDO ARIAMedo.ai · Radiology
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