System, X-Ray, Tomography, Computed
FDA product code JAK · Class II (moderate risk) · 21 CFR 892.1750 · Radiology
823510(k) clearances
0PMA approvals
823recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 105
- GE Medical Systems, LLC 68
- Toshiba America Medical Systems, In.C 35
- General Electric Co. 31
- Toshibamedical Systems Corporation 27
- Philips Medical Systems (Cleveland) Inc 24
- Canon Medical Systems Corporation 23
- GE Medical Systems SCS 16
- Elscint, Inc. 16
- Shimadzu Medical Systems 14
- Siemens Medical Systems, Inc. 14
- Shanghai United Imaging Healthcare Co., Ltd. 12
- Neusoft Medical Systems Co., Ltd. 12
- Hitachi Medical Systems America, Inc. 12
- Philips Medical Systems North America, Inc. 10
- Siemens Corp. 10
- Siemens AG Medical Solutions 10
- Superdimension, Ltd. 10
- Philips Medical Systems 8
- Philips Healthcare (Suzhou) Co., Ltd. 8
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
| K253520 | Photonova Spectra, Photonova Spectra SelectJAK · Traditional | Ge Medical Systems, LLC | 03/20/2026SE |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0JAK · Traditional | Canon Medical Systems Corporation | 03/13/2026SE |
| K252249 | Extremity CT Imaging SystemJAK · Traditional | Mars Bioimaging , Ltd. | 03/13/2026SE |
| K260167 | Bunkerhill Contrast AVCJAK · Traditional | BunkerHill Health | 03/06/2026SE |
| K260166 | Bunkerhill Contrast CACJAK · Traditional | BunkerHill Health | 03/06/2026SE |
| K260169 | AV Cardiac CTJAK · Traditional | Philips Medical Systems Nederland B.V. | 03/05/2026SE |
| K253173 | uCT 780 with uWS-CT-Dual Energy AnalysisJAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 01/20/2026SE |
| K252217 | CT VScore+JAK · Traditional | Canon Medical Informatics, Inc. | 11/28/2025SE |
| K251805 | syngo.CT Dual EnergyJAK · Traditional | Siemens Medical Solutions USA, Inc. | 10/15/2025SE |
| K250662 | Bunkerhill MACJAK · Traditional | BunkerHill Health | 10/03/2025SE |
| K250766 | LungQ 4JAK · Traditional | Thirona BV | 10/02/2025SE |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…JAK · Traditional | Canon Medical Systems Corporation | 09/26/2025SE |
| K250928 | OmniTom Elite with PCDJAK · Traditional | Neurologica Corporation | 09/08/2025SE |
| K251484 | Ct:VqJAK · Traditional | 4Dmedical Limited | 08/28/2025SE |
| K250941 | Revolution VibeJAK · Traditional | Ge Medical Systems, LLC | 08/01/2025SE |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAK · Traditional | Siemens Medical Solutions USA, Inc. | 07/28/2025SE |
| K250970 | MarieJAK · Traditional | Leo Cancer Care | 07/25/2025SE |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…JAK · Traditional | Siemens Medical Solutions USA, Inc. | 07/03/2025SE |
| K250648 | Philips iCT CT systemJAK · Traditional | Philips Medical Systems Nederland B.V. | 06/27/2025SE |
| K243398 | CT Scanner TSX-501R/1 V11.1JAK · Traditional | Canon Medical Systems Corporation | 06/20/2025SE |
| K243672 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 06/18/2025SE |
| K250370 | SCENARIA View Phase 5.0JAK · Traditional | Fujifilm Corporation | 05/20/2025SE |
| K244008 | Spectral CTJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 05/16/2025SE |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy…JAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/16/2025SE |
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionJAK · Traditional | Arineta , Ltd. | 04/15/2025SE |
| K243240 | Vitrea CT VScoreJAK · Traditional | Canon Medical Informatics, Inc. | 04/10/2025SE |
| K242811 | BodyTom 64JAK · Traditional | Neurologica Corporation, A Subsidiary of Samsung | 03/14/2025SE |
| K242411 | Brainomix 360 e-LungJAK · Traditional | Brainomix Limited | 02/19/2025SE |
| K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAK · Traditional | Siemens Medical Solutions USA, Inc. | 02/12/2025SE |
| K243229 | Bunkerhill AVCJAK · Traditional | BunkerHill Health | 01/27/2025SE |
| K241166 | uCT 550JAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 01/14/2025SE |
| K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionJAK · Traditional | Arineta , Ltd. | 01/13/2025SE |
| K241079 | uCT 780JAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 01/07/2025SE |
| K241757 | syngo.CT Dual EnergyJAK · Traditional | Siemens Medical Solutions USA, Inc. | 01/03/2025SE |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5JAK · Traditional | Canon Medical Systems Corporation | 12/23/2024SE |
| K242188 | ClearRead CT CACJAK · Traditional | Riverain Technologies, Inc. | 12/03/2024SE |
| K242874 | Gating Reflector BlockJAK · Traditional | Varian Medical Systems, Inc. | 11/21/2024SE |
| K240844 | Spectral CT 7500 RTJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 10/18/2024SE |
| K240369 | CAC (gated) AlgorithmJAK · Traditional | BunkerHill Health | 09/27/2024SE |
| K241295 | SOMATOM On.siteJAK · Traditional | Siemens Medical Solutions USA, Inc. | 09/03/2024SE |
| K241440 | HealthCCSngJAK · Special | Nano-X AI , Ltd. | 08/19/2024SE |
| K233731 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 08/01/2024SE |
| K241713 | HiRise (1040-230)JAK · Special | Curvebeam, LLC | 07/12/2024SE |
| K233767 | OmniTom EliteJAK · Traditional | Neurologica Corporation | 06/10/2024SE |
| K233875 | Brainomix 360 e-LungJAK · Traditional | Brainomix Limited | 05/13/2024SE |
| K232491 | CT 5300JAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 05/03/2024SE |
| K233583 | FCT iSTREAM Phase 1JAK · Traditional | FUJIFILM Healthcare Americas Corporation | 04/26/2024SE |
| K233698 | True Enhance DLJAK · Traditional | Ge Healthcare Japan Corporation | 04/11/2024SE |
| K232227 | Ablate-IqJAK · Traditional | Neuwave Medical, Inc. | 04/04/2024SE |
| K233750 | ECG-less CardiacJAK · Traditional | Ge Medical Systems, LLC | 04/02/2024SE |
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemJAK · Traditional | Canon Medical Systems Corporation | 04/02/2024SE |
| K233657 | NAEOTOM AlphaJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/28/2024SE |
| K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…JAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/26/2024SE |
| K233753 | AI-Rad Companion (Pulmonary)JAK · Abbreviated | Siemens Healthcare GmbH | 03/21/2024SE |
| K232022 | CAS-One IRJAK · Traditional | Cascination AG | 03/13/2024SE |
| K233749 | Revolution Ascend SlidingJAK · Special | Ge Hangwei Medical Systems Co., Ltd. | 02/22/2024SE |
| K233080 | HealthFLDJAK · Traditional | Nano-X AI , Ltd. | 02/08/2024SE |
| K234030 | Clear Guide SCENERGYJAK · Special | Clear Guide Medical | 01/17/2024SE |
| K232412 | LungQ v3.0.0JAK · Traditional | Thirona BV | 01/08/2024SE |
| K232136 | syngo.CT ApplicationsJAK · Traditional | Siemens Medical Solutions USA, Inc. | 01/04/2024SE |
| K233334 | Aquilion Serve SP (TSX-307B/1) V1.3JAK · Special | Canon Medical Systems Corporation | 12/06/2023SE |
| K232206 | SOMATOM Pro.PulseJAK · Traditional | Siemens Medical Solutions USA, Inc. | 12/06/2023SE |
| K232155 | syngo.CT Dual EnergyJAK · Traditional | Siemens Medical Solutions USA, Inc. | 11/30/2023SE |
| K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy…JAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/29/2023SE |
| K231631 | BriefCase-QuantificationJAK · Traditional | Aidoc Medical , Ltd. | 11/28/2023SE |
| K232392 | CT Lung Ventilation Analysis Software (CT:V)JAK · Traditional | 4Dmedical Limited | 11/16/2023SE |
| K232045 | MeVis Liver SuiteJAK · Traditional | MeVis Medical Solutions AG | 10/27/2023SE |
| K230370 | SpotLight/SpotLight Duo (with DLIR option)JAK · Traditional | Arineta , Ltd. | 10/13/2023SE |
| K231574 | Scenaria View 4.2JAK · Traditional | FUJIFILM Healthcare Americas Corporation | 10/12/2023SE |
| K230220 | NeuViz 128 Multi-Slice CT Scanner SystemJAK · Traditional | Neusoft Medical Systems Co., Ltd. | 10/11/2023SE |
| K230130 | Micromate Navi+JAK · Traditional | Isys Medizintechnik GmbH | 10/10/2023SE |
| K231281 | Aquilion Serve (TSX-307A/1) V1.3JAK · Traditional | Canon Medical Systems Corporation | 09/19/2023SE |
| K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisJAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/01/2023SE |
| K223424 | Spine Auto ViewsJAK · Traditional | GE Medical Systems SCS | 07/13/2023SE |
| K223261 | Open RibJAK · Traditional | Canon Medical Informatics, Inc. | 07/13/2023SE |
| K230421 | SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition…JAK · Traditional | Siemens Medical Solutions USA, Inc. | 06/16/2023SE |
| K230112 | CAC SoftwareJAK · Traditional | Imbio, Inc. | 06/13/2023SE |
| K223447 | OmniTom EliteJAK · Traditional | Neurologica Corporation, A Subsidiary of Samsung | 06/01/2023SE |
| K223758 | EpioneJAK · Traditional | Quantum Surgical Sas | 05/03/2023SE |
| K230223 | iCAC DeviceJAK · Traditional | Bunkerhill, Inc. | 04/25/2023SE |
| K230807 | Deep Learning Image ReconstructionJAK · Special | Ge Healthcare Japan Corporation | 04/20/2023SE |
| K222360 | AI-Rad Companion (Cardiovascular)JAK · Traditional | Siemens Medical Solutions U.S.A. | 04/06/2023SE |
| K223514 | Spectral Bone MarrowJAK · Traditional | Ge Medical Systems, LLC | 03/09/2023SE |
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCEJAK · Traditional | Canon Medical Systems Corporation | 03/07/2023SE |
| K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iJAK · Traditional | Canon Medical Systems Corporation | 03/03/2023SE |
| K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisJAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/16/2023SE |
| K223804 | PercuNav Image Fusion and Interventional Navigation SystemJAK · Traditional | Philips Ultrasound, LLC | 01/18/2023SE |
| K223311 | Philips CT 3500JAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 12/22/2022SE |
| K213465 | CardioGrapheJAK · Traditional | Arineta , Ltd. | 12/02/2022SE |
| K222361 | AI-Rad Companion (Musculoskeletal)JAK · Traditional | Siemens Medical Solutions USA, Inc. | 10/20/2022SE |
| K213759 | XACT Robotic System, ACE ModelJAK · Traditional | Xact Robotics, Ltd. | 09/23/2022SE |
| K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCEJAK · Traditional | Canon Medical Systems Corporation | 09/12/2022SE |
| K220910 | Medical image processing softwareJAK · Traditional | Hangzhou Deepwise & League of PHD Technology… | 08/11/2022SE |
| K213713 | AI-Rad Companion (Pulmonary)JAK · Traditional | Siemens Healthcare GmbH | 08/11/2022SE |
| K220961 | Deep Learning Image ReconstructionJAK · Special | Ge Healthcare Japan Corporation | 07/29/2022SE |
| K221727 | syngo.CT Extended FunctionalityJAK · Special | Siemens Medical Solutions USA, Inc. | 07/13/2022SE |
| K220814 | NAEOTOM Alpha, Scan&GO SoftwareJAK · Traditional | Siemens Medical Solutions USA, Inc. | 07/12/2022SE |
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…JAK · Traditional | Canon Medical Systems Corporation | 06/16/2022SE |
| K213829 | SCENARIA ViewJAK · Traditional | Fujifilm Healthcare Corporation | 05/23/2022SE |
| K221219 | syngo.CT CaScoringJAK · Special | Siemens Medical Solutions USA, Inc. | 05/17/2022SE |
| K221116 | XACT ACE Robotic SystemJAK · Special | Xact Robotics, Ltd. | 05/13/2022SE |
| K212875 | Spectral CT on RailsJAK · Traditional | Philips Medical Systems Nederland B.V. | 05/13/2022SE |
| K220664 | NewTom 7GJAK · Traditional | Cefla S.C. | 05/06/2022SE |
| K211180 | Liver SuiteJAK · Traditional | GE Medical Systems SCS | 05/02/2022SE |
| K213649 | BodyTom 64JAK · Traditional | Neurologica Corporation | 04/29/2022SE |
| K212441 | Philips Incisive CTJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 04/27/2022SE |
| K213944 | HealthOSTJAK · Traditional | Nanoxai , Ltd. | 04/22/2022SE |
| K212889 | Syngo.CT Dual EnergyJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/28/2022SE |
| K213725 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 03/11/2022SE |
| K220450 | syngo.CT ApplicationsJAK · Special | Siemens Medical Solutions USA, Inc. | 03/07/2022SE |
| K211711 | OmniTom EliteJAK · Traditional | Neurologica Corporation, A Subsidiary of Samsung… | 02/25/2022SE |
| K211645 | EpioneJAK · Traditional | Quantum Surgical Sas | 02/24/2022SE |
| K213999 | Deep Learning Image ReconstructionJAK · Traditional | Ge Medical Systems, LLC | 02/18/2022SE |
| K213938 | Revolution AscendJAK · Traditional | Ge Healthcare Japan Corporation | 02/04/2022SE |
| K214019 | syngo.CT Extended FunctionalityJAK · Special | Siemens Medical Solutions USA, Inc. | 01/20/2022SE |
| K213927 | Respiratory Gating for Scanners v2.0JAK · Special | Varian Medical Systems, Inc. | 01/14/2022SE |
| K210760 | Precise ImageJAK · Traditional | Philips Medical Systems Nederland B.V. | 01/14/2022SE |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…JAK · Special | Ge Medical Systems, LLC | 12/17/2021SE |
| K213096 | Al-Rad Companion (Pulmonary)JAK · Traditional | Siemens Medical Solutions USA, Inc. | 12/06/2021SE |
| K211168 | Philips Incisive CT on TrailerJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 11/22/2021SE |
| K211591 | NAEOTOM Alpha, Scan&GOJAK · Traditional | Siemens Medical Solutions USA, Inc. | 09/30/2021SE |
| K212067 | Deep Learning Image ReconstructionJAK · Traditional | Ge Healthcare Japan Corporation | 09/17/2021SE |
| K210085 | HealthCCSngJAK · Traditional | Zebra Medical Vision, Ltd. | 09/15/2021SE |
| K211828 | Aquilion Exceed LBJAK · Traditional | Canon Medical Systems Corporation | 09/10/2021SE |
| K212494 | Lung Image AnalysisJAK · Traditional | Pulmonx Corporation | 09/02/2021SE |
| K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X.…JAK · Traditional | Siemens Medical Solutions USA, Inc. | 08/27/2021SE |
| K203448 | uCT ATLAS with uWS-CT-Dual Energy AnalysisJAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/11/2021SE |
| K203411 | syngo.CT Skull UnfoldingJAK · Traditional | Siemens Medical Solutions USA, Inc. | 07/22/2021SE |
| K203720 | MicromateJAK · Traditional | Isys Medizintechnik GmbH | 06/22/2021SE |
| K203514 | Precise PositionJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 06/17/2021SE |
| K203699 | syngo. CT Extended FunctionalitiesJAK · Traditional | Siemens Medical Solutions USA, Inc. | 04/30/2021SE |
| K203225 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemJAK · Traditional | Canon Medical Systems Corporation | 03/24/2021SE |
| K203617 | MaxFOV 2JAK · Traditional | Ge Medical Systems, LLC | 03/02/2021SE |
| K203020 | Spectral CTJAK · Traditional | Philips Medical Systems Nederland B.V. | 02/26/2021SE |
| K200626 | VesselIQ XpressJAK · Traditional | GE Medical Systems SCS | 02/16/2021SE |
| K201231 | CTxx85 CT ScannerJAK · Traditional | Analogic Corporation | 02/02/2021SE |
| K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iJAK · Traditional | Canon Medical Systems Corporation | 01/12/2021SE |
| K202526 | OmniTom EliteJAK · Traditional | Neurologica Corporation, A Subsidiary of Samsung… | 12/23/2020SE |
| K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-IJAK · Traditional | Canon Medical Systems Corporation | 12/10/2020SE |
| K201745 | Deep Learning Image Reconstruction for Gemstone Spectral ImagingJAK · Traditional | Ge Medical Systems, LLC | 12/10/2020SE |
| K203216 | The Multimodality Advanced Vessel AnalysisJAK · Traditional | Philips Medical Systems Nederland B.V. | 11/25/2020SE |
| K203169 | Revolution AscendJAK · Special | Ge Healthcare Japan Corporation | 11/20/2020SE |
| K203187 | HiRiseJAK · Traditional | Curvebeam, LLC | 11/18/2020SE |
| K193289 | FastStroke, CT Perfusion 4DJAK · Traditional | GE Medical Systems SCS | 11/12/2020SE |
| K201092 | LSNJAK · Traditional | Imaging Biometrics, LLC | 10/29/2020SE |
| K202213 | syngo.CT Neuro PerfusionJAK · Traditional | Siemens Medical Solutions USA, Inc. | 10/11/2020SE |
| K201188 | Clear Guide SCENERGYJAK · Traditional | Clear Guide Medical | 09/30/2020SE |
| K200990 | VIDAvisionJAK · Traditional | Vida Diagnostics, Inc. | 08/07/2020SE |
| K201898 | Clear Guide SCENERGYJAK · Traditional | Clear Guide Medical | 07/31/2020SE |
| K193277 | SOMATOM On.site and On.sceneJAK · Traditional | Siemens Medical Solutions USA, Inc. | 07/22/2020SE |
| K200498 | SCENARIA ViewJAK · Traditional | Hitachi Healthcare Americas | 07/17/2020SE |
| K201586 | XACT Robotic SystemJAK · Special | Xact Robotics, Ltd. | 07/09/2020SE |
| K193073 | Deep ReconJAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/06/2020SE |
| K201053 | PercuNav Image Fusion and Interventional NavigationJAK · Traditional | Philips Ultrasound, Inc. | 05/14/2020SE |
| K201034 | Syngo.CT CaScoringJAK · Special | Siemens Medical Solutions USA, Inc. | 05/14/2020SE |
| K193293 | XV Lung Ventilation Analysis SoftwareJAK · Traditional | 4Dx Limited | 05/14/2020SE |
| K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…JAK · Special | Siemens Medical Solutions USA, Inc. | 04/01/2020SE |
| K200515 | syngo.CT Cardiac PlanningJAK · Special | Siemens Medical Soultions USA, Inc. | 03/25/2020SE |
| K193281 | Hepatic VCARJAK · Traditional | GE Medical Systems SCS | 03/20/2020SE |
| K193267 | Al-Rad Companion (Musculoskeletal)JAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/16/2020SE |
| K192590 | Cura 778JAK · Traditional | Fmi Medical Systems, Inc. | 03/05/2020SE |
| K191550 | BroncholabJAK · Traditional | Fluidda, Inc. | 03/04/2020SE |
| K200016 | uCT 530, uCT 550JAK · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/25/2020SE |
| K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iJAK · Traditional | Canon Medical Systems Corporation | 02/21/2020SE |
| K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemJAK · Traditional | Canon Medical Systems Corporation | 02/13/2020SE |
| K193454 | IQon Spectral CTJAK · Traditional | Philips Medical Systems Nederland B.V. | 01/24/2020SE |
| K192956 | Auto PositioningJAK · Traditional | Ge Hangwei Medical Systems Co., Ltd. | 01/16/2020SE |
| K192763 | syngo.CT CaScoringJAK · Traditional | Siemens Medical Solutions USA, Inc. | 12/17/2019SE |
| K193170 | Deep Learning Image ReconstructionJAK · Special | Ge Healthcare Japan Corporation | 12/13/2019SE |
| K192061 | SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…JAK · Traditional | Siemens Medical Solutions USA, Inc. | 11/21/2019SE |
| K191891 | SOMATOM X.citeJAK · Traditional | Siemens Medical Solutions USA, Inc. | 11/06/2019SE |
| K192686 | Revolution Maxima, Revolution AceJAK · Special | Ge Hangwei Medical Systems Co., Ltd. | 10/24/2019SE |
| K192427 | Ablation ConfirmationJAK · Special | Neuwave Medical, Inc. | 10/03/2019SE |
| K191332 | XACT Robotic SystemJAK · Traditional | Xact Robotics, Ltd. | 10/03/2019SE |
| K192402 | syngo.CT Extended FunctionalityJAK · Special | Siemens Medical Solutions USA, Inc. | 09/20/2019SE |
| K190841 | SCENARIA ViewJAK · Traditional | Hitachi Healthcare Americas | 09/13/2019SE |
| K183268 | AI-Rad Companion (Cardiovascular)JAK · Traditional | Siemens Medical Solutions USA, Inc. | 09/10/2019SE |
| K192188 | Aquilion ONE (TSX-306A/3) V10.0JAK · Special | Canon Medical Systems Corporation | 09/06/2019SE |
| K191394 | ILLUMISITE PlatformJAK · Traditional | Covidien, LLC | 08/07/2019SE |
| K191136 | Access CTJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 07/29/2019SE |
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionJAK · Special | Ge Medical Systems, LLC | 07/26/2019SE |
| K183271 | AI-Rad Companion (Pulmonary)JAK · Traditional | Siemens Medical Solutions USA, Inc. | 07/26/2019SE |
| K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCEJAK · Traditional | Canon Medical Systems Corporation | 07/05/2019SE |
| K191468 | syngo.CT Dual EnergyJAK · Special | Siemens Medical Solutions USA, Inc. | 07/03/2019SE |
| K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…JAK · Traditional | Siemens Medical Solutions USA, Inc. | 06/27/2019SE |
| K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCEJAK · Traditional | Canon Medical Systems Corporation | 06/12/2019SE |
| K190505 | Low Dose Lung Screening OptionJAK · Traditional | Canon Medical Systems Corporation | 06/05/2019SE |
| K182716 | Brain Perfusion (BP) applicationJAK · Traditional | Philips Medical Systems Nederland B.V. | 05/29/2019SE |
| K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16JAK · Traditional | Siemens Medical Solutions USA, Inc. | 04/15/2019SE |
| K183202 | Deep Learning Image ReconstructionJAK · Traditional | Ge Medical Systems, LLC | 04/12/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3043-2026 Class II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-3042-2026 Class II | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-3041-2026 Class II | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-3040-2026 Class II | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP.…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-2988-2026 Class II | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Potential of failing to trigger clinical scan during Bolus Tracking. | Philips Healthcare (Suzhou) Co., Ltd. | 06/26/2026Open, Classified |
| Z-2652-2026 Class II | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium…The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be… | Philips Medical Systems | 06/11/2026Open, Classified |
| Z-2651-2026 Class II | IQon Spectral CT IQon Spectral CT UpgradesThe clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be… | Philips Medical Systems | 06/11/2026Open, Classified |
| Z-2650-2026 Class II | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000…The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be… | Philips Medical Systems | 06/11/2026Open, Classified |
| Z-2155-2026 Class II | Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison… | GE Medical Systems, LLC | 03/26/2026Open, Classified |
| Z-2154-2026 Class II | Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison… | GE Medical Systems, LLC | 03/26/2026Open, Classified |
| Z-2153-2026 Class II | Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison… | GE Medical Systems, LLC | 03/26/2026Open, Classified |
| Z-2152-2026 Class II | Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison… | GE Medical Systems, LLC | 03/26/2026Open, Classified |
| Z-2151-2026 Class II | Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison… | GE Medical Systems, LLC | 03/26/2026Open, Classified |
| Z-2150-2026 Class II | Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison… | GE Medical Systems, LLC | 03/26/2026Open, Classified |
| Z-2149-2026 Class II | Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison… | GE Medical Systems, LLC | 03/26/2026Open, Classified |
| Z-1825-2026 Class II | Philips Spectral CT on Rails. Model Number: 728334.Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential… | Philips Medical Systems | 03/07/2026Open, Classified |
| Z-1590-2026 Class II | Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT)…There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position… | GE Medical Systems, LLC | 02/03/2026Open, Classified |
| Z-1318-2026 Class II | Spectral CT 7500 on Rails; Product Code (REF): 728334;As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the… | Philips North America Llc | 01/07/2026Open, Classified |
| Z-1317-2026 Class II | Spectral CT; Product Code (REF): 728333;As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the… | Philips North America Llc | 01/07/2026Open, Classified |
| Z-1316-2026 Class II | IQon Spectral CT; Product Code (REF): 728332;As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the… | Philips North America Llc | 01/07/2026Open, Classified |
| Z-1315-2026 Class II | Brilliance iCT; Product Code (REF): 728306;As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the… | Philips North America Llc | 01/07/2026Open, Classified |
| Z-1242-2026 Class II | NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel…To remove the software applications from certain CT systems as the applications have not received FDA 510(k)… | Siemens Medical Solutions USA, Inc | 12/19/2025Open, Classified |
| Z-1241-2026 Class II | NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel…To remove the software applications from certain CT systems as the applications have not received FDA 510(k)… | Siemens Medical Solutions USA, Inc | 12/19/2025Open, Classified |
| Z-1240-2026 Class II | NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel…To remove the software applications from certain CT systems as the applications have not received FDA 510(k)… | Siemens Medical Solutions USA, Inc | 12/19/2025Open, Classified |
| Z-1239-2026 Class II | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel…To remove the software applications from certain CT systems as the applications have not received FDA 510(k)… | Siemens Medical Solutions USA, Inc | 12/19/2025Open, Classified |
| Z-1041-2026 Class II | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray…AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Mobius Imaging, LLC | 12/04/2025Open, Classified |
| Z-1040-2026 Class II | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray…AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Mobius Imaging, LLC | 12/04/2025Open, Classified |
| Z-1003-2026 Class II | Philips Incisive CTPotential for incomplete scan due to unstable connection inside of floating sensor. | Philips Healthcare (Suzhou) Co., Ltd. | 12/03/2025Open, Classified |
| Z-0882-2026 Class II | CT 5300; Software Version Number: 4.5, 5.0, 5.1;If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This… | Philips North America Llc | 10/29/2025Open, Classified |
| Z-0881-2026 Class II | Incisive CT; Software Version Number: 4.5, 5.0, 5.1;If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This… | Philips North America Llc | 10/29/2025Open, Classified |
| Z-0377-2026 Class II | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions:…Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is… | Philips Medical Systems | 09/25/2025Open, Classified |
| Z-0376-2026 Class II | Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is… | Philips Medical Systems | 09/25/2025Open, Classified |
| Z-0375-2026 Class II | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions:…Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is… | Philips Medical Systems | 09/25/2025Open, Classified |
| Z-0225-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0224-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0223-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0222-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0221-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0220-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0219-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0218-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-0217-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | UIH Technologies LLC | 09/12/2025Open, Classified |
| Z-2604-2025 Class II | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |
| Z-2603-2025 Class II | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |
| Z-2602-2025 Class II | Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |
| Z-2601-2025 Class II | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |
| Z-2600-2025 Class II | Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number:…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |
| Z-2599-2025 Class II | Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |
| Z-2598-2025 Class II | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |
| Z-2597-2025 Class II | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2.…The patient support table (couch) may descend unexpectedly to the lowermost position due to a component… | Philips North America Llc | 08/13/2025Open, Classified |