AI devices with FDA product code JAK — System, X-Ray, Tomography, Computed
Product code JAK (“System, X-Ray, Tomography, Computed” in openFDA) covers 103 devices on the FDA AI-enabled list, from 40 companies. Most are reviewed by the Radiology panel (103). The most recent decision was Enhanced Boundary for PCCT on June 24, 2026.
103AI devices
31Companies
2014First decision
2026-06-24Latest decision
Trend: devices per year
2014201820192020202120222023202420252026
Top companies
All 103 devices, newest first
- Enhanced Boundary for PCCTGe Medical Systems, LLC · Radiology
- Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · Radiology
- Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd. · 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
- Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · Radiology
- Bunkerhill Contrast CACBunkerHill Health · Radiology
- Bunkerhill Contrast AVCBunkerHill Health · Radiology
- AV Cardiac CTPhilips Medical Systems Nederland B.V. · Radiology
- uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · Radiology
- CT VScore+Canon Medical Informatics, Inc. · Radiology
- Bunkerhill MACBunkerhill Health · Radiology
- LungQ 4Thirona BV · Radiology
- Revolution VibeGE Medical Systems, LLC · Radiology
- CardIQ SuiteGE Medical Systems SCS · Radiology
- SCENARIA View Phase 5.0FUJIFILM Corporation · Radiology
- uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co.,Ltd. · Radiology
- SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta Ltd. · Radiology
- NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc. · Radiology
- Bunkerhill AVCBunkerHill Health · Radiology
- uCT 550Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta Ltd. · Radiology
- uCT 780Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · Radiology
- ClearRead CT CACRiverain Technologies, Inc. · Radiology
- CAC (gated) AlgorithmBunkerHill Health · Radiology
- HealthCCSngNano-X AI Ltd. · Radiology
- CardIQ SuiteGE Medical Systems SCS · Radiology
- CT 5300Philips Healthcare (Suzhou) Co., Ltd. · Radiology
- True Enhance DLGE Healthcare Japan Corporation · Radiology
- Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 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
- AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · Radiology
- Revolution Ascend SlidingGE Hangwei Medical Systems Co., Ltd. · Radiology
- HealthFLDNano-X AI Ltd. · Radiology
- LungQ v3.0.0Thirona BV · Radiology
- Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation · Radiology
- BriefCase-QuantificationAidoc Medical, Ltd. · Radiology
- MeVis Liver SuiteMeVis Medical Solutions AG · Radiology
- SpotLight/SpotLight Duo (with DLIR option)Arineta Ltd. · Radiology
- NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · Radiology
- Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · Radiology
- Spine Auto ViewsGE Medical Systems SCS · Radiology
- CAC SoftwareImbio, Inc. · Radiology
- iCAC DeviceBunkerhill, Inc · Radiology
- Deep Learning Image ReconstructionGE Healthcare Japan Corporation · Radiology
- AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A. · Radiology
- Spectral Bone MarrowGE Medical Systems, LLC · 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
- uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Philips CT 3500Philips Healthcare (Suzhou) Co., Ltd · Radiology
- AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. · Radiology
- Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems Corporation · Radiology
- AI-Rad Companion (Pulmonary)Siemens Healthcare GmBh · Radiology
- Deep Learning Image ReconstructionGE Healthcare Japan Corporation · Radiology
- syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · Radiology
- Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · Radiology
- syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · Radiology
- Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · Radiology
- HealthOSTNanoxAI Ltd. · Radiology
- CardIQ SuiteGE Medical Systems SCS · Radiology
- Deep Learning Image ReconstructionGE Medical Systems, LLC. · Radiology
- Revolution AscendGE Healthcare Japan Corporation · Radiology
- syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · Radiology
- Precise ImagePhilips Medical Systems Nederland, B.V. · Radiology
- Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · Radiology
- Deep Learning Image ReconstructionGE Healthcare Japan Corporation · Radiology
- HealthCCSngZebra Medical Vision Ltd. · Radiology
- Aquilion Exceed LBCanon Medical Systems Corporation · Radiology
- uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Precise PositionPhilips Healthcare (Suzhou) Co., Ltd. · Radiology
- Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation · Radiology
- MaxFOV 2GE Medical Systems, LLC. · Radiology
- Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · Radiology
- Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation · Radiology
- Deep Learning Image Reconstruction for Gemstone Spectral ImagingGE Medical Systems, LLC · Radiology
- Revolution AscendGE Healthcare Japan Corporation · Radiology
- FastStroke, CT Perfusion 4DGE Medical Systems SCS · Radiology
- VIDAvisionVIDA Diagnostics Inc. · Radiology
- Deep ReconShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · Radiology
- Hepatic VCARGE Medical Systems SCS · Radiology
- Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. · Radiology
- BroncholabFluidda Inc. · Radiology
- Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation · Radiology
- Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation · Radiology
- Auto PositioningGE Hangwei Medical Systems, Co., Ltd. · Radiology
- syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · Radiology
- Deep Learning Image ReconstructionGE Healthcare Japan Corporation · Radiology
- AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · Radiology
- AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · Radiology
- Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical Systems Corporation · Radiology
- Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation · Radiology
- Deep Learning Image ReconstructionGE Medical Systems, LLC. · Radiology
- Bone VCAR (BVCAR)GE Medical Systems SCS · Radiology
- HealthCCSZebra Medical Vision Ltd. · Radiology
- LungQ SoftwareThirona Corporation · Radiology
- Lung Density AnalysisIMBIO LLC · Radiology
- HEPATIC VCARGE MEDICAL SYSTEMS SCS · Radiology