Radiology · 2026 so farRadiology AI devices by month in 2026: Jan 20, Feb 14, Mar 35, Apr 20, May 24, Jun 22
FDA-cleared AI devices for radiology 2026
2026 is still in progress (FDA decisions through June 29, 2026): 135 radiology AI devices so far, against 254 in all of 2025. That is 11% of the 1,230 radiology devices on the FDA list, and 74.6% of all AI-device decisions dated 2026. The most active were Ge Medical Systems, LLC (5), Philips Ultrasound, LLC (5), Shanghai United Imaging Healthcare Co., Ltd. (5). The newest is Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd., decided on June 29, 2026.
1352026 devices
92Companies
74.6%Of all 2026 AI devices
11%Of all radiology
Companies in 2026
By month
JanFebMarAprMayJun
Product codes
QIHAutomated Radiological Image Processing Software48IYNSystem, Imaging, Pulsed Doppler, Ultrasonic15JAKSystem, X-Ray, Tomography, Computed12LNHSystem, Nuclear Magnetic Resonance Imaging9QASRadiological Computer-Assisted Triage And Notification Software8QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer6QKBRadiological Image Processing Software For Radiation Therapy6MYNAnalyzer, Medical Image4All 135 devices
- Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd. · Radiology
- ADAS 3DAdas3D Medical S.L. · Radiology
- Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- MammoScreen® (5)Therapixel · Radiology
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- Enhanced Boundary for PCCTGe Medical Systems, LLC · Radiology
- CMN Capillary Function with Oncology Virtual ExpertCercare Medical A/S · Radiology
- RadOncAIInformai · Radiology
- ARTHURROPCA ApS · Radiology
- Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health · Radiology
- Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation · 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
- MediAI-OACrescom Co., Ltd. · Radiology
- LungMapsSiemens Healthineers AG · Radiology
- Saige-DxDeepHealth, Inc. · 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
- DeepXray SpinaAlpha Intelligence Manifolds, Inc. · Radiology
- DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd. · Radiology
- Sonio SuspectSonio · Radiology
- HeartFocusDeski · Radiology
- HistoSonics® Planning ToolHistoSonics, Inc. · Radiology
- OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc. · Radiology
- ANDI 2.2Imeka Solutions, Inc. · Radiology
- Synapse Lung Nodule AIFujifilm Corporation · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · Radiology
- uMR AstraShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc. · Radiology
- uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteWuhan United Imaging Healthcare Co.,Ltd · Radiology
- BACDeepHealth, Inc. · Radiology
- MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S. · Radiology
- Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · Radiology
- Neurophet SCALE PETNeurophet., Inc. · Radiology
- uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperWuhan United Imaging Healthcare Co.,Ltd · Radiology
- SubtleHD-CT (1.x)Subtle Medical, Inc. · Radiology
- Neurophet AQUANeurophet., Inc. · Radiology
- UNiD Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic) · Radiology
- SubtleHD-PET (1.x)Subtle Medical, Inc. · Radiology
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- MorphBeauBrain Healthcare, Inc. · Radiology
- RayvolveAZmed · Radiology
- Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc. · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- MammoSightAINeurocareai, Inc. (Dba Savelife.Ai) · Radiology
- Intelligent NRCanon, Inc. · Radiology
- Synapse 3D Base Tools (V7.2)Fujifilm Corporation · Radiology
- DeepHealth ProstateAIQuantib B.V. · Radiology
- syngo Application SoftwareSiemens Medical Solutions USA, Inc. · Radiology
- OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICAL · Radiology
- Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · Radiology
- DS Core CBCT AnatomyDentsply Sirona · Radiology
- uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd. · Radiology
- FolliscanMim Fertility · Radiology
- EdgeFlow UW20Edgecare, Inc. · Radiology
- Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC · Radiology
- DeepBT Detector-PlusAitewan Biomedical Technology, Inc. · Radiology
- AI-Rad Companion Organs RTSiemens Healthcare GmbH · Radiology
- Relu CloudRelu BV · Radiology
- syngo Dynamics (VA41F)Siemens Healthcare GmbH · Radiology
- Overjet Iris Intelligent Imaging SystemOverjet, Inc. · Radiology
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · Radiology
- uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- CoLumbo C-SpineSmart Soft Healthcare AD · Radiology
- AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · Radiology
- Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd. · Radiology
- Butterfly Gestational Age ToolButterfly Network, Inc. · Radiology
- Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- S-scan Open (100001800)Esaote, S.p.A. · Radiology
- Contour ProtégéAI+Mim Software, Inc. · Radiology
- Lunit INSIGHT DBT (V1.2)Lunit, Inc. · Radiology
- SwiftMRAirs Medical, Inc. · Radiology
- TriniasShimadzu Corporation · Radiology
- JLK-NCCTJLK, Inc. · Radiology
- LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · Radiology
- True Definition DLGe Healthcare Japan Corporation · Radiology
- Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC · Radiology
- SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc. · Radiology
- AutoContour (RADAC V5)Radformation, Inc. · Radiology
- syngo.via RT Image Suite VC10Varian Medical Systems, Inc. · Radiology
- EchoNavigator R5.0Philips Medical Systems Nederland B.V. · Radiology
- Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated · Radiology
- Sonio Detect (v3)Sonio · Radiology
- InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd. · Radiology
- Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · Radiology
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation · Radiology
- LiverMultiScan (v6.0)Perspectum, Ltd. · Radiology
- Bunkerhill Contrast CACBunkerHill Health · Radiology
- Bunkerhill Contrast AVCBunkerHill Health · Radiology
- VELYS Hip NavigationDepuy Ireland UC · Radiology
- CEPHX3DOrca Dental AI , Ltd. · Radiology
- AV Cardiac CTPhilips Medical Systems Nederland B.V. · Radiology
- Magnifico Open (100009900)Esaote, S.p.A. · Radiology
- QT Scanner 2000 Model AQT Imaging Holdings, Inc. · Radiology
- Annalise EnterpriseHarrison-AI Medical Pty, Ltd. · Radiology
- Clarius Ejection Fraction AIClarius Mobile Health Corp. · Radiology
- Ligence HeartLigence Uab · Radiology
- BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd. · Radiology
- AI Platform 2.2 (AIP002)Exo Imaging · Radiology
- Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including UpgradesPhilips Medical Systems Nederland B.V. · Radiology
- MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance , Ltd. · Radiology
- CARA SystemCara Medical, Ltd. · Radiology
- Monaco RTP System (6.3)Elekta Solutions AB · Radiology
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Delivery Date AIUltrasound AI · Radiology
- AI4CMR v2.0Ai4medimaging Medical Solutions S.A. · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
- Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies · Radiology
- SIGNA BoltGe Medical Systems, LLC · Radiology
- SIGNA Sprint SelectGe Medical Systems, LLC · Radiology
- RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx · Radiology
- Surgical Reality ViewerMedicalvr B.V. · Radiology
- Neurophet AQUA AD PlusNeurophet., Inc. · Radiology
- Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd. · Radiology
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- AccuContour 4.0Manteia Technologies Co., Ltd. · Radiology
- AV VascularPhilips Medical Systems Nederland B.V. · Radiology
- AI-Rad Companion Brain MRSiemens Healthcare GmbH · Radiology
- uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · Radiology
- qXR-DetectQure.Ai Technologies · Radiology
- Imagine® Enterprise SuiteSoftlink International Private Limited · Radiology
- DiagnocatDGNCT, LLC · Radiology
- BIOGRAPH OneSiemens Healthineers AG · Radiology
- EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)Elekta Solutions AB · Radiology
- VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd. · Radiology
- LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- DS Core DetectDentsply Sirona, Inc. · Radiology
- BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd. · Radiology
- LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2026?
Through June 29, 2026, 135 AI-enabled radiology devices have a 2026 decision. That is 11% of all 1,230 radiology devices on the list.
How does 2026 compare with 2025 for AI radiology devices?
2026 is still in progress (FDA decisions through June 29, 2026): 135 radiology AI devices so far, against 254 in all of 2025.
Which companies cleared the most AI radiology devices in 2026?
Ge Medical Systems, LLC (5), Philips Ultrasound, LLC (5), Shanghai United Imaging Healthcare Co., Ltd. (5).
What was the most recent AI radiology device in 2026?
Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd. (K253628), decided on June 29, 2026. Product code QIH.
Which product codes were most common for AI radiology devices in 2026?
QIH (Automated Radiological Image Processing Software): 48; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 15; JAK (System, X-Ray, Tomography, Computed): 12.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2026,” https://ai-device-radar.vercel.app/specialty/radiology/2026 (FDA list through 2026-06-29).