Radiology · 2023Radiology AI devices by month in 2023: Jan 5, Feb 14, Mar 20, Apr 19, May 11, Jun 7, Jul 17, Aug 6, Sep 16, Oct 25, Nov 18, Dec 20
FDA-cleared AI devices for radiology 2023
2023 has 178 radiology AI devices, 29% more than 2022 (138). That is 14.5% of the 1,230 radiology devices on the FDA list, and 78.8% of all AI-device decisions dated 2023. The most active were Siemens Medical Solutions USA, Inc. (10), Canon Medical Systems Corporation (7), Annalise-AI Pty Ltd (6). The newest is TumorSight Viz from SimBioSys, Inc., decided on December 26, 2023.
1782023 devices
114Companies
78.8%Of all 2023 AI devices
14.5%Of all radiology
Companies in 2023
By month
JanFebMarAprMayJunJulAugSepOctNovDec
Product codes
QIHAutomated Radiological Image Processing Software44LLZSystem, Image Processing, Radiological23IYNSystem, Imaging, Pulsed Doppler, Ultrasonic19LNHSystem, Nuclear Magnetic Resonance Imaging16JAKSystem, X-Ray, Tomography, Computed15QASRadiological Computer-Assisted Triage And Notification Software11MYNAnalyzer, Medical Image10QFMRadiological Computer-Assisted Prioritization Software For Lesions8All 178 devices
- TumorSight VizSimBioSys, Inc. · Radiology
- MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc. · Radiology
- ART-PlanTheraPanacea · Radiology
- qXR-LNQure.ai Technologies · Radiology
- HM70 EVO Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd. · Radiology
- MAGNETOM Cima.XSiemens Medical Solutions USA, Inc. · Radiology
- iQ-solutionsSydney Neuroimaging Analysis Centre Pty Ltd · Radiology
- Videa Dental AssistVideaHealth, Inc. · Radiology
- StrokeViewer PerfusionNICo-Lab B.V. · Radiology
- QP-Brain®Quibim S.L. · Radiology
- Transpara Density 1.0.0Screenpoint Medical B.V. · Radiology
- DTX Studio Clinic (4.0)Nobel Biocare AB · Radiology
- BonelogicDisior Ltd · Radiology
- LOGIQ TotusGE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- Myocardial Strain Software ApplicationCircle Cardiovascular Imaging · Radiology
- Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation · Radiology
- Adravision PerioAdra Corporation · Radiology
- Ceevra Reveal 3+Ceevra, Inc. · Radiology
- Syngo Carbon ClinicalsSiemens Healthcare GmbH · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- 6440 MyLabX90Esaote S.p.A. · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- Brainomix 360 Triage StrokeBrainomix Limited · Radiology
- AI Platform (AIP001)Exo Inc · Radiology
- Axial3D InsightAxial Medical Printing Limited · Radiology
- MAGNETOM Avanto fit; MAGNETOM Skyra fitSiemens Medical Solutions USA, Inc. · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- Clarius Bladder AIClarius Mobile Health Corp. · Radiology
- BraveCXBering Ltd · Radiology
- MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc. · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- Contour ProtégéAIMIM Software Inc. · Radiology
- LOGIQ E10GE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- LOGIQ E10s, LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostic, · Radiology
- Lunit INSIGHT DBTLunit Inc. · Radiology
- aprevo® Digital SegmentationCarlsmed, Inc. · Radiology
- BriefCase-TriageAidoc Medical, Ltd. · Radiology
- Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- MeVis Liver SuiteMeVis Medical Solutions AG · Radiology
- SwiftMRAIRS Medical Inc. · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · Radiology
- Rapid SDHiSchemaView, Inc. · Radiology
- AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A. · Radiology
- MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · Radiology
- Ultrasound System 1300BK Medical Aps · Radiology
- Sonix HealthOntact Health Co., Ltd. · Radiology
- Veuron-Brain-pAb3Heuron Co., Ltd. · Radiology
- SpotLight/SpotLight Duo (with DLIR option)Arineta Ltd. · Radiology
- NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · Radiology
- Denti.AI DetectDenti.AI Technology, Inc. · Radiology
- Swoop® Portable MR Imaging System®Hyperfine, Inc. · Radiology
- cmAngio® V1.0CureMetrix, Inc. · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- DeepTek CXR Analyzer v1.0DeepTek Medical Imaging Pvt Ltd · Radiology
- Momentum SpineMomentum Health Inc. · Radiology
- EFAI NeuroSuite CT ICH Assessment SystemEver Fortune.AI Co., Ltd. · Radiology
- VUNO Med-DeepBrainVUNO Inc. · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Lung-CADImagen Technologies, Inc · Radiology
- HipCheckStryker Corp. · Radiology
- Brainomix 360 Triage LVOBrainomix Limited · Radiology
- OFIX MIS AppOrthofix US LLC · Radiology
- EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.AI Co., Ltd. · Radiology
- Annalise Enterprise CTB Triage TraumaAnnalise-AI Pty Ltd · Radiology
- qXR-CTRQure.ai Technologies · Radiology
- JazzAI Medical AG · Radiology
- Annalise Enterprise CTB Triage TraumaAnnalise-AI Pty Ltd. · Radiology
- Overjet Periapical Radiolucency AssistOverjet, Inc · Radiology
- Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · Radiology
- NEUROShieldIn-Med Prognostics L3C · Radiology
- Lung-CADImagen Technologies, Inc · Radiology
- Cartesion Prime (PCD-1000A/3) V10.15Canon Medical Systems Corporation · Radiology
- XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation · Radiology
- DeepXrayAlpha Intelligence Manifolds, Inc. · Radiology
- MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc. · Radiology
- Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- VisAble.IOTechsoMed · Radiology
- AIRAscoreAIRAmed GmbH · Radiology
- qXR-PTX-PEQure.ai Technologies · Radiology
- Annalise Enterprise CTB Triage-OHAnnalise-AI Pty Ltd · Radiology
- VisiRad XRImidex Inc. · Radiology
- Brainomix 360 Triage ICHBrainomix Limited · Radiology
- Rapid Aneurysm Triage and NotificationiSchemaView Inc. · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- ANDIImeka Solutions, Inc. · Radiology
- Sonio DetectSonio · Radiology
- UltraSight AI GuidanceUltraSight Inc. · Radiology
- OptimMRIRebrAIn, SAS · Radiology
- uOmnispaceShanghai United Imaging Healthcare Co., Ltd · Radiology
- syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbH · 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
- Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc. · Radiology
- Spine Auto ViewsGE Medical Systems SCS · Radiology
- ECHELON Synergy MRI systemFUJIFILM Healthcare Corporation · Radiology
- MOZI TPSManteia Technologies Co., Ltd. · Radiology
- Spine CAMP (1.1)Medical Metrics, Inc. · Radiology
- Axial3D InsightAxial Medical Printing Limited · Radiology
- Bladder AI (AIBV01)Exo Inc · Radiology
- HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty Ltd · Radiology
- Voluson SWIFT; Voluson SWIFT+GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC · Radiology
- DeepCatchMEDICALIP Co., Ltd · Radiology
- IB Lab LAMAIB Lab GmbH · Radiology
- CAC SoftwareImbio, Inc. · Radiology
- FEops HEARTguideTM, FEops HEARTguideTM ALPACAFEops nv · Radiology
- Sonic DLGE Medical Systems,LLC (GE Healthcare) · Radiology
- Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care SuiteGE Medical Systems, LLC · Radiology
- Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc. · Radiology
- AutoplaqueCedars-Sinai Medical Center: AIM · Radiology
- Radiation Planning Assistant (RPA)University of Texas, MD Anderson Cancer Center · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- SubtleMR (2.3.x)Subtle Medical Inc. · Radiology
- Neurophet AQUANEUROPHET, Inc. · Radiology
- Auto SegmentationGE Medical Systems, LLC · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · Radiology
- SIS SystemSurgical Information Sciences, Inc. · Radiology
- Precision DLGE Healthcare · Radiology
- MR DWI/FLAIR Measurement V1.0Olea Medical · Radiology
- iCAC DeviceBunkerhill, Inc · Radiology
- Ceevra Reveal 3Ceevra, Inc. · Radiology
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- ViewFinder Software Version 1.1Elaitra Ltd · Radiology
- VelacurSonic Incytes · Radiology
- Deep Learning Image ReconstructionGE Healthcare Japan Corporation · Radiology
- ART-PlanTherapanacea SAS · Radiology
- Quantib ProstateQuantib BV · Radiology
- AutoContour Model RADAC V3Radformation, Inc. · Radiology
- Ezra FlashEzra AI, Inc. · Radiology
- CerebralGo PlusYukun (Beijing) Technology Co., Ltd · Radiology
- Ultrasound System 2300BK Medical Aps · Radiology
- Limbus ContourLimbus AI Inc. · Radiology
- AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A. · Radiology
- Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V. · Radiology
- Contour ProtégéAIMIM Software Inc. · Radiology
- Annalise Enterprise CTB Triage TraumaAnnalise-AI Pty Ltd · Radiology
- Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · Radiology
- Formus HipFormus Labs, Ltd · Radiology
- RayStation 12ARaySearch Laboratories AB (publ) · Radiology
- DTX Studio Clinic 3.0Nobel Biocare AB · Radiology
- RadioLens v1.0Synapsica · Radiology
- Annalise Enterprise CXR Triage TraumaAnnalise-AI Pty Ltd · Radiology
- Annalise Enterprise CXR Triage TraumaAnnalise-AI Pty Ltd · Radiology
- MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA Inc. · Radiology
- Overjet Caries AssistOverjet, Inc. · Radiology
- MPXA-2000Medipixel, Inc. · Radiology
- FlightPlan for EmbolizationGE Medical Systems SCS · Radiology
- Viz AAAViz. ai, Inc. · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Spectral Bone MarrowGE Medical Systems, LLC · Radiology
- AccuContourManteia Technologies Co., Ltd. · Radiology
- Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems Corporation · Radiology
- Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · Radiology
- BoneViewGleamer · Radiology
- Rapid NCCT StrokeiSchemaView, Inc. · Radiology
- Xeleris V Processing and Review SystemGE Healthcare · Radiology
- Caption Interpretation Automated Ejection Fraction SoftwareCaption Health, Inc · Radiology
- AVIEW Lung Nodule CADCoreline Soft Co.,Ltd. · Radiology
- Brainomix 360 e-ASPECTSBrainomix Limited · Radiology
- BoneMRI v1.6MRIguidance B.V. · Radiology
- Swoop® Portable MR Imaging SystemHyperfine, Inc. · Radiology
- uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · Radiology
- uMR 680Shanghai United Imaging Intelligence Co., Ltd. · Radiology
- SIGNA VictorGE Healthcare (Tianjin) Company Limited · Radiology
- V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Videa Perio AssistVideaHealth, Inc. · Radiology
- OncospaceOncospace, Inc. · Radiology
- LVivo IQSDiA Imaging Analysis Ltd · Radiology
- Rapid RV/LViSchema View Inc. · Radiology
- BriefCaseAidoc Medical, Ltd. · Radiology
- QOCA image Smart CXR Image Processing SystemQuanta Computer Inc. · Radiology
- Clarius AIClarius Mobile Health Corp. · Radiology
- TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · Radiology
- MR Diffusion Perfusion Mismatch V1.0Olea Medical · Radiology
- AIBOLIT 3D+Aibolit Technologies, LLC · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2023?
178 AI-enabled radiology devices have a final decision dated 2023, from 114 companies.
How does 2023 compare with 2022 for AI radiology devices?
2023 has 178 radiology AI devices, 29% more than 2022 (138).
Which companies cleared the most AI radiology devices in 2023?
Siemens Medical Solutions USA, Inc. (10), Canon Medical Systems Corporation (7), Annalise-AI Pty Ltd (6).
What was the most recent AI radiology device in 2023?
TumorSight Viz from SimBioSys, Inc. (K231130), decided on December 26, 2023. Product code QIH.
Which product codes were most common for AI radiology devices in 2023?
QIH (Automated Radiological Image Processing Software): 44; LLZ (System, Image Processing, Radiological): 23; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 19.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2023,” https://ai-device-radar.vercel.app/specialty/radiology/2023 (FDA list through 2026-06-29).