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103 devices · 40 companies · 2014 to 2026

Product code JAK: System, X-Ray, Tomography, Computed

103 devices under product code JAK, 2014 to 2026, from 40 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (103 of 103 here), the regulation, and MAUDE report counts by product code.

System, X-Ray, Tomography, Computed. 21 CFR 892.1750, Class II. MAUDE held 5,281 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved from FDA public records.

Companies with more than one device here

Every device, newest decision first

JAK · 103 devices
DecisionDeviceCompanyPanelFDA
Enhanced Boundary for PCCTK253560 · 510(k)Ge Medical Systems, LLCRadiologydatabase entry
Aquilion ONEK253596 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Spectral CT Verida FamilyK253649 · 510(k)Philips Medical Systems Technologies , Ltd.Radiologydatabase entry
CT Rembra RTK252992 · 510(k)Philips Healthcare (Suzhou) Co., Ltd.Radiologydatabase entry
True Definition DLK253686 · 510(k)Ge Healthcare Japan CorporationRadiologydatabase entry
Photonova Spectra, Photonova Spectra SelectK253520 · 510(k)Ge Medical Systems, LLCRadiologydatabase entry
SOMATOM X.citeK253574 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Aquilion ServeSPK260078 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Bunkerhill Contrast CACK260166 · 510(k)BunkerHill HealthRadiologydatabase entry
Bunkerhill Contrast AVCK260167 · 510(k)BunkerHill HealthRadiologydatabase entry
AV Cardiac CTK260169 · 510(k)Philips Medical Systems Nederland B.V.Radiologydatabase entry
uCT 780 with uWS-CT-Dual Energy AnalysisK253173 · 510(k)Shanghai United Imaging Healthcare Co., Ltd.Radiologydatabase entry
CT VScore+K252217 · 510(k)Canon Medical Informatics, Inc.Radiologydatabase entry
Bunkerhill MACK250662 · 510(k)Bunkerhill HealthRadiologydatabase entry
LungQ 4K250766 · 510(k)Thirona BVRadiologydatabase entry
Revolution VibeK250941 · 510(k)GE Medical Systems, LLCRadiologydatabase entry
CardIQ SuiteK243672 · 510(k)GE Medical Systems SCSRadiologydatabase entry
SCENARIA View Phase 5.0K250370 · 510(k)FUJIFILM CorporationRadiologydatabase entry
uCT ATLAS Astound with uWS-CT-Dual Energy AnalysK243617 · 510(k)Shanghai United Imaging Healthcare Co.,Ltd.Radiologydatabase entry
SpotLight / SpotLight Duo with Low Dose Lung CanK250650 · 510(k)Arineta Ltd.Radiologydatabase entry
NAEOTOM Alpha.Peak/ NAEOTOM AlphaK243523 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Bunkerhill AVCK243229 · 510(k)BunkerHill HealthRadiologydatabase entry
uCT 550K241166 · 510(k)Shanghai United Imaging Healthcare Co., Ltd.Radiologydatabase entry
SpotLight/SpotLight Duo with Low Dose Lung CanceK241200 · 510(k)Arineta Ltd.Radiologydatabase entry
uCT 780K241079 · 510(k)Shanghai United Imaging Healthcare Co., Ltd.Radiologydatabase entry
Aquilion ONEK242403 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
ClearRead CT CACK242188 · 510(k)Riverain Technologies, Inc.Radiologydatabase entry
CACK240369 · 510(k)BunkerHill HealthRadiologydatabase entry
HealthCCSngK241440 · 510(k)Nano-X AI Ltd.Radiologydatabase entry
CardIQ SuiteK233731 · 510(k)GE Medical Systems SCSRadiologydatabase entry
CT 5300K232491 · 510(k)Philips Healthcare (Suzhou) Co., Ltd.Radiologydatabase entry
True Enhance DLK233698 · 510(k)GE Healthcare Japan CorporationRadiologydatabase entry
Aquilion ONEK232835 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
NAEOTOM AlphaK233657 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
SOMATOM go.UpK233650 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
AI-Rad CompanionK233753 · 510(k)Siemens Healthcare GmbHRadiologydatabase entry
Revolution Ascend SlidingK233749 · 510(k)GE Hangwei Medical Systems Co., Ltd.Radiologydatabase entry
HealthFLDK233080 · 510(k)Nano-X AI Ltd.Radiologydatabase entry
LungQ v3.0.0K232412 · 510(k)Thirona BVRadiologydatabase entry
Aquilion Serve SPK233334 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
BriefCase-QuantificationK231631 · 510(k)Aidoc Medical, Ltd.Radiologydatabase entry
MeVis Liver SuiteK232045 · 510(k)MeVis Medical Solutions AGRadiologydatabase entry
SpotLight/SpotLight DuoK230370 · 510(k)Arineta Ltd.Radiologydatabase entry
NeuViz 128 Multi-Slice CT Scanner SystemK230220 · 510(k)Neusoft Medical Systems Co., Ltd.Radiologydatabase entry
Aquilion ServeK231281 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Spine Auto ViewsK223424 · 510(k)GE Medical Systems SCSRadiologydatabase entry
CAC SoftwareK230112 · 510(k)Imbio, Inc.Radiologydatabase entry
iCAC DeviceK230223 · 510(k)Bunkerhill, IncRadiologydatabase entry
Deep Learning Image ReconstructionK230807 · 510(k)GE Healthcare Japan CorporationRadiologydatabase entry
AI-Rad CompanionK222360 · 510(k)Siemens Medical Solutions U.S.A.Radiologydatabase entry
Spectral Bone MarrowK223514 · 510(k)GE Medical Systems, LLCRadiologydatabase entry
Aquilion PrecisionK223726 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Aquilion ServeK222819 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
uCT ATLAS Astound with uWS-CT-Dual Energy AnalysK223028 · 510(k)Shanghai United Imaging Healthcare Co., Ltd.Radiologydatabase entry
Philips CT 3500K223311 · 510(k)Philips Healthcare (Suzhou) Co., LtdRadiologydatabase entry
AI-Rad CompanionK222361 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Aquilion PrecisionK220986 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
AI-Rad CompanionK213713 · 510(k)Siemens Healthcare GmBhRadiologydatabase entry
Deep Learning Image ReconstructionK220961 · 510(k)GE Healthcare Japan CorporationRadiologydatabase entry
syngo.CT Extended FunctionalityK221727 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Aquilion ONEK213504 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
syngo.CT CaScoringK221219 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Philips Incisive CTK212441 · 510(k)Philips Healthcare (Suzhou) Co., Ltd.Radiologydatabase entry
HealthOSTK213944 · 510(k)NanoxAI Ltd.Radiologydatabase entry
CardIQ SuiteK213725 · 510(k)GE Medical Systems SCSRadiologydatabase entry
Deep Learning Image ReconstructionK213999 · 510(k)GE Medical Systems, LLC.Radiologydatabase entry
Revolution AscendK213938 · 510(k)GE Healthcare Japan CorporationRadiologydatabase entry
syngo.CT Extended FunctionalityK214019 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Precise ImageK210760 · 510(k)Philips Medical Systems Nederland, B.V.Radiologydatabase entry
Al-Rad CompanionK213096 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Deep Learning Image ReconstructionK212067 · 510(k)GE Healthcare Japan CorporationRadiologydatabase entry
HealthCCSngK210085 · 510(k)Zebra Medical Vision Ltd.Radiologydatabase entry
Aquilion Exceed LBK211828 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
uCT ATLAS with uWS-CT-Dual Energy AnalysisK203448 · 510(k)Shanghai United Imaging Healthcare Co., Ltd.Radiologydatabase entry
Precise PositionK203514 · 510(k)Philips Healthcare (Suzhou) Co., Ltd.Radiologydatabase entry
Aquilion ONEK203225 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
MaxFOV 2K203617 · 510(k)GE Medical Systems, LLC.Radiologydatabase entry
Aquilion LightningK201836 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Aquilion Exceed LBK203042 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Deep Learning Image Reconstruction for GemstoneK201745 · 510(k)GE Medical Systems, LLCRadiologydatabase entry
Revolution AscendK203169 · 510(k)GE Healthcare Japan CorporationRadiologydatabase entry
FastStroke, CT Perfusion 4DK193289 · 510(k)GE Medical Systems SCSRadiologydatabase entry
VIDAvisionK200990 · 510(k)VIDA Diagnostics Inc.Radiologydatabase entry
Deep ReconK193073 · 510(k)Shanghai United Imaging Healthcare Co., Ltd.Radiologydatabase entry
Syngo.CT CaScoringK201034 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Hepatic VCARK193281 · 510(k)GE Medical Systems SCSRadiologydatabase entry
Al-Rad CompanionK193267 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
BroncholabK191550 · 510(k)Fluidda Inc.Radiologydatabase entry
Aquilion Prime SPK192832 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Aquilion ONEK192828 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Auto PositioningK192956 · 510(k)GE Hangwei Medical Systems, Co., Ltd.Radiologydatabase entry
syngo.CT CaScoringK192763 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Deep Learning Image ReconstructionK193170 · 510(k)GE Healthcare Japan CorporationRadiologydatabase entry
AI-Rad CompanionK183268 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
AI-Rad CompanionK183271 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Aquilion PrecisionK182901 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Aquilion ONEK183046 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Deep Learning Image ReconstructionK183202 · 510(k)GE Medical Systems, LLC.Radiologydatabase entry
Bone VCARK183204 · 510(k)GE Medical Systems SCSRadiologydatabase entry
HealthCCSK172983 · 510(k)Zebra Medical Vision Ltd.Radiologydatabase entry
LungQ SoftwareK173821 · 510(k)Thirona CorporationRadiologydatabase entry
Lung Density AnalysisK141069 · 510(k)IMBIO LLCRadiologydatabase entry
HEPATIC VCARK133649 · 510(k)GE MEDICAL SYSTEMS SCSRadiologydatabase entry

Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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