Radiology · 2024Radiology AI devices by month in 2024: Jan 13, Feb 9, Mar 14, Apr 19, May 13, Jun 12, Jul 10, Aug 22, Sep 16, Oct 20, Nov 16, Dec 19
FDA-cleared AI devices for radiology 2024
2024 has 183 radiology AI devices, 2.8% more than 2023 (178). That is 14.9% of the 1,230 radiology devices on the FDA list, and 77.9% of all AI-device decisions dated 2024. The most active were Siemens Medical Solutions USA, Inc. (12), Shanghai United Imaging Healthcare Co., Ltd. (7), Canon Medical Systems Corporation (6). The newest is Aquilion ONE (TSX-308A/3) V1.5 from Canon Medical Systems Corporation, decided on December 23, 2024.
1832024 devices
125Companies
77.9%Of all 2024 AI devices
14.9%Of all radiology
Companies in 2024
By month
JanFebMarAprMayJunJulAugSepOctNovDec
Product codes
QIHAutomated Radiological Image Processing Software63IYNSystem, Imaging, Pulsed Doppler, Ultrasonic22JAKSystem, X-Ray, Tomography, Computed14LNHSystem, Nuclear Magnetic Resonance Imaging13QASRadiological Computer-Assisted Triage And Notification Software12LLZSystem, Image Processing, Radiological10QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer7POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer6All 183 devices
- Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · Radiology
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics · Radiology
- Lightning ViewerNexsys Electronics Inc. dba Medweb · Radiology
- Saige-Density (2.5.0)DeepHealth, Inc · Radiology
- OrthoNext Platform SystemOrthofix Srl · Radiology
- IQ-UIPImbio, Inc. · Radiology
- Saige-Dx (3.1.0)DeepHealth, Inc. · Radiology
- MSKaiMSKai · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co.,Ltd. · Radiology
- BriefCase-TriageAidoc Medical, Ltd. · Radiology
- IRISegIntuitive Surgical Inc. · Radiology
- V5 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. · Radiology
- AutoContour (Model RADAC V4)Radformation, Inc. · Radiology
- DrAid for Liver SegmentationVinBrain Joint Stock Company · Radiology
- EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)Ever Fortune.AI, Co., Ltd. · Radiology
- CDM InsightsOxford Brain Diagnostics Ltd · Radiology
- PeekMed webPeek Health, S.A. · Radiology
- ClearRead CT CACRiverain Technologies, Inc. · Radiology
- Sonix HealthOntact Health Co., Ltd · Radiology
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Transpara (2.1.0)ScreenPoint Medical B.V. · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- Strain AI (SAI001)Exo Inc · Radiology
- ACUSON 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. · Radiology
- Saige-DxDeepHealth, Inc · Radiology
- Koios DSKoios Medical, Inc. · Radiology
- VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno Inc. · Radiology
- The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- 1CMR ProMycardium AI Limited · Radiology
- Fetal EchoScanBrightHeart · Radiology
- ProFound Detection (V4.0)iCAD, Inc. · Radiology
- NeuroICHNeurocareai Inc. · Radiology
- icobrain ariaicometrix NV · 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
- nordicMEDiVANordicNeurolab AS · Radiology
- Contour+ (MVision AI Segmentation)MVision AI Oy · Radiology
- BriefCase-TriageAidoc Medical, Ltd. · Radiology
- SIGNA MAGNUSGE Medical Systems, LLC · Radiology
- cvi42 Software ApplicationCircle Cardiovascular Imaging Inc. · Radiology
- HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- EchoMeasureiCardio.ai · Radiology
- Limbus ContourLimbus AI Inc. · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- SpineUs SystemVerdure Imaging · Radiology
- Lunit INSIGHT DBT v1.1Lunit Inc. · Radiology
- EchoSolv ASEcho IQ Ltd · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd. · Radiology
- Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- MammoScreen BDTherapixel · Radiology
- LungVisionBodyVision Medical Ltd. · Radiology
- MuscleViewSpringbok, Inc. · Radiology
- CAC (gated) AlgorithmBunkerHill Health · Radiology
- JBS-LVOJLK, Inc. · Radiology
- uAI Easy Triage ICHShanghai United Imaging Intelligence Co., Ltd. · Radiology
- MAMMOMAT B.brilliant with Tomosynthesis OptionSIEMENS MEDICAL SOLUTIONS USA, INC. · Radiology
- PIUR tUS InfinityPIUR Imaging GmbH · Radiology
- Constellation (CON-001)Q Bio, Inc. · Radiology
- CINA-CSpineAvicenna.AI · Radiology
- Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)Canon Medical Systems Corporation · Radiology
- FETOLY-HEARTDiagnoly · Radiology
- LumiNE US; LumiAugmedit B.V. · Radiology
- ADAS 3DAdas3D Medical S.L · Radiology
- Overjet Image Enhancement AssistOverjet Inc · Radiology
- See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte. Ltd. · Radiology
- uAI PortalShanghai United Imaging Intelligence Co., Ltd. · Radiology
- TRAQinform IQAIQ Global, Inc. · Radiology
- VelacurSonic Incytes · Radiology
- Velmeni for Dentists (V4D)Velmeni Inc. · Radiology
- Imbio PHA (4.0.0)Imbio, Inc · Radiology
- uMI PanoramaShanghai United Imaging Healthcare Co.,Ltd. · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
- syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- KosmosEchoNous, Inc. · Radiology
- Overjet Charting AssistOverjet, Inc · Radiology
- NeuroQuantCorTechs Labs, Inc. · Radiology
- AiMIFY (1.x)Subtle Medical, Inc. · Radiology
- Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- HealthCCSngNano-X AI Ltd. · Radiology
- qCT LN QuantQure.ai Technologies · Radiology
- uMI PanvivoShanghai United Imaging Healthcare Co., Ltd. · Radiology
- CoLumboSmart Soft Healthcare · Radiology
- ECHELON Synergy MRI SystemFUJIFILM Healthcare Corporation · Radiology
- OptimMRI (v2)Rebrain, SAS · Radiology
- i2ContourMRIMath LLC · Radiology
- Omni LegendGE Medical Systems Israel, Functional Imaging · Radiology
- AI Platform 2.0 (AIP002)Exo Imaging · Radiology
- AISAP Cardio V1.0Aisap · Radiology
- CardIQ SuiteGE Medical Systems SCS · Radiology
- MammoScreen® (3)Therapixel · Radiology
- ACUSON 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. · Radiology
- RayvolveAZmed SAS · Radiology
- MICSI-RMTMicrostructure Imaging, Inc. · Radiology
- Swoop® Portable MR Imaging® SystemHyperfine, Inc. · Radiology
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · Radiology
- RUSHutom Inc. · Radiology
- BriefCase-TriageAidoc Medical, Ltd. · Radiology
- SubtleSYNTH (1.x)Subtle Medical, Inc. · Radiology
- SMART Bun-Yo-Matic X-RayDisior Ltd · Radiology
- Hyper Insight - ICHSK Inc. · Radiology
- VEA Align; spineEOSEOS imaging · Radiology
- V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- O-arm O2 Imaging SystemMedtronic Navigation, Inc · Radiology
- Medihub ProstateJLK Inc. · Radiology
- SMART Bun-Yo-Matic CTDisior Ltd · Radiology
- SIS SystemSurgical Information Sciences, Inc. · Radiology
- Clarius OB AIClarius Mobile Health Corp. · Radiology
- Radiography 7300 CPhilips Medical Systems DMC GmbH · Radiology
- Relu CreatorRelu BV · Radiology
- RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 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
- CINA-VCFAvicenna.AI · Radiology
- uPMR 790Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- LVivo IQSDiA Imaging Analysis Ltd. · Radiology
- Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH · Radiology
- VinDr-MammoVinBigData Joint Stock Company · Radiology
- YSIO X.preeSiemens Medical Solutions · Radiology
- uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Heuron ICHHeuron Co., Ltd. · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- SmartChestMilvue · Radiology
- DeepContour (V1.0)Wisdom Technologies., Inc. · Radiology
- ECHELON Synergy V10.0Fujifilm Healthcare Americas Corporation · Radiology
- CT 5300Philips Healthcare (Suzhou) Co., Ltd. · Radiology
- Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems Inc. · Radiology
- syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · Radiology
- Sonio DetectSonio · Radiology
- uMR JupiterShanghai United Imaging Healthcare Co., Ltd · Radiology
- InVision Precision LVEF (LVEF)InVision Medical Technology Corporation · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- ART-Plan (v.2.2.0)Therapanacea SAS · Radiology
- RapidiSchema View Inc. · Radiology
- uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- VisAble.IOTechsomed · Radiology
- Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- True Enhance DLGE Healthcare Japan Corporation · Radiology
- uMR 680Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Rho16 Bit Inc · Radiology
- EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEMEver Fortune.AI, Co., Ltd. · Radiology
- Preview ShoulderGenesis Software Innovations · Radiology
- AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A. · Radiology
- Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · Radiology
- Us2.v2Eko.ai Pte. Ltd d/b/a Us2.ai · Radiology
- AVIEW CACCoreline Soft Co., Ltd. · Radiology
- NAEOTOM AlphaSiemens Medical Solutions USA, Inc. · Radiology
- SOMATOM 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. · Radiology
- MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc. · Radiology
- syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. · Radiology
- uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · Radiology
- AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · Radiology
- CINA-ASPECTSAvicenna.AI · Radiology
- CINA-iPEAvicenna.AI · Radiology
- Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- EdgeFlow UH10Edgecare Inc. · Radiology
- Overjet Caries Assist-PediatricOverjet, Inc · Radiology
- BoneMRIMRIguidance B.V · Radiology
- iCAS-LVHighRAD Ltd. · Radiology
- MAGNETOM Cima.X FitSiemens Medical Solutions USA, Inc. · Radiology
- inHEART ModelsinHEART, SAS · Radiology
- CT CardiomegalyInnolitics, LLC · Radiology
- Overjet Charting AssistOverjet, Inc · Radiology
- Revolution Ascend SlidingGE Hangwei Medical Systems Co., Ltd. · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- QOCA® image Smart RT Contouring SystemQuanta Computer Inc. · Radiology
- HealthFLDNano-X AI Ltd. · Radiology
- Viz HDS, Viz Volume Plus, Viz ICH+Viz.ai, Inc. · Radiology
- CEPHX- Cephalometric Analysis SoftwareOrca Dental AI LTD · Radiology
- Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation · Radiology
- SIGNA ChampionGE Healthcare (Tianjin) Company Limited · Radiology
- Rapid ASPECTS (v3)iSchemaView, Inc. · Radiology
- NemoScanSoftware Nemotec S.L. · Radiology
- Radify TriageEnvisionit DeepAI Ltd · Radiology
- Rapid (6.0)iSchemaView, Inc. · Radiology
- Biograph VK10Siemens Medical Solutions USA, Inc. · Radiology
- FibresolveImvaria, Inc · Radiology
- DASI Dimensions (V1.0)DASI Simulations · Radiology
- LungQ v3.0.0Thirona BV · Radiology
- VEA AlignEOS imaging · Radiology
- Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2024?
183 AI-enabled radiology devices have a final decision dated 2024, from 125 companies.
How does 2024 compare with 2023 for AI radiology devices?
2024 has 183 radiology AI devices, 2.8% more than 2023 (178).
Which companies cleared the most AI radiology devices in 2024?
Siemens Medical Solutions USA, Inc. (12), Shanghai United Imaging Healthcare Co., Ltd. (7), Canon Medical Systems Corporation (6).
What was the most recent AI radiology device in 2024?
Aquilion ONE (TSX-308A/3) V1.5 from Canon Medical Systems Corporation (K242403), decided on December 23, 2024. Product code JAK.
Which product codes were most common for AI radiology devices in 2024?
QIH (Automated Radiological Image Processing Software): 63; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 22; JAK (System, X-Ray, Tomography, Computed): 14.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2024,” https://ai-device-radar.vercel.app/specialty/radiology/2024 (FDA list through 2026-06-29).