System, X-Ray, Tomography, Computed
Regulation 892.1750
22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
Top companies in JAK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | PHILIPS MEDICAL SYSTEMS Spectral CT and Spectral CT 7500 RT;
Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.);
Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 ( Open, Classified |
JAK | K244008 |
| Sep 29, 2026 | Philips North America Llc Philips Medical Systems
Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333 Open, Classified |
JAK | K244008 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS Astound with software Open, Classified |
JAK | K203448 K231482 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT ATLAS with software Open, Classified |
JAK | K203448 K231482 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 780 with software Open, Classified |
JAK | K172135 K230162 +2 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 760 with software Open, Classified |
JAK | K172135 K230162 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 550 with software Open, Classified |
JAK | K181414 K200016 +1 |
| Sep 25, 2026 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model: uCT 530 with software Open, Classified |
JAK | K181414 K200016 |
| Sep 1, 2026 | Philips North America Llc Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x Open, Classified |
JAK | K033326 |
| Sep 1, 2026 | Philips North America Llc Philips Ingenuity CT
Product Codes: Ingenuity CT Upgrades 728327,
Ingenuity CT China 728324,
Ingenuity Core 128 Elite Brazil 728325.
Software 4.4.10.x Open, Classified |
JAK | K160743 |
| Sep 1, 2026 | Philips North America Llc Philips IQon Spectral CT
Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331
Software 4.7.7.x Open, Classified |
JAK | K193454 |
| Sep 1, 2026 | Philips North America Llc Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x
Product Codes: 728306, 728305, 728311. Open, Classified |
JAK | K250648 |
| Aug 21, 2026 | Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144. Open, Classified |
JAK | K212441 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS Ingenuity CT
CT5000 Ingenuity Plus
CT5000 Ingenuity Pro
CT5000 Ingenuity Premium
Ingenuity CT Upgrades
Ingenuity CT China
Ingenuity Core 128 Elite Brazil Open, Classified |
JAK | K160743 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS IQon Spectral CT
IQon Spectral CT Upgrades Open, Classified |
JAK | K193454 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS Brilliance iCT
Brilliance iCT Upgrades
Brilliance iCT SP
Brilliance CT 64 Channel
CT6000
Brilliance 64 Upgrades Open, Classified |
JAK | K250648 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 Open, Classified |
JAK | K213715 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 Open, Classified |
JAK | K163213 K191777 +1 |
| May 8, 2026 | GE Medical Systems, LLC Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 Open, Classified |
JAK | K163213 K191777 +1 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 Open, Classified |
JAK | K191777 K213715 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 Open, Classified |
JAK | K213715 |
| May 8, 2026 | GE Medical Systems, LLC Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 Open, Classified |
JAK | K133705 K163213 +2 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 Open, Classified |
JAK | K213938 |
| Apr 16, 2026 | PHILIPS MEDICAL SYSTEMS Philips Spectral CT on Rails. Model Number: 728334. Open, Classified |
JAK | K212875 |
| Mar 20, 2026 | GE Medical Systems, LLC Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP Open, Classified |
JAK | K162314 |
| Feb 6, 2026 | Philips North America Llc Spectral CT 7500 on Rails;
Product Code (REF): 728334; Open, Classified |
JAK | K212875 |
| Feb 6, 2026 | Philips North America Llc Spectral CT;
Product Code (REF): 728333; Open, Classified |
JAK | K244008 |
| Feb 6, 2026 | Philips North America Llc IQon Spectral CT;
Product Code (REF): 728332; Open, Classified |
JAK | K193454 |
| Feb 6, 2026 | Philips North America Llc Brilliance iCT;
Product Code (REF): 728306; Open, Classified |
JAK | K250648 |
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc NAEOTOM Alpha.Pro
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS Open, Classified |
JAK | K251061 |
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc NAEOTOM Alpha.Prime
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS Open, Classified |
JAK | K251061 |
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc NAEOTOM Alpha
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS Open, Classified |
JAK | K251061 |
| Feb 3, 2026 | Siemens Medical Solutions USA, Inc SOMATOM X.ceed
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS Open, Classified |
JAK | K233650 |
| Jan 9, 2026 | Mobius Imaging, LLC Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. Open, Classified |
JAK | K180393 |
| Jan 9, 2026 | Mobius Imaging, LLC Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. Open, Classified |
JAK | K180393 |
| Jan 8, 2026 | Philips Healthcare (Suzhou) Co., Ltd. Philips Incisive CT Open, Classified |
JAK | K180015 K212441 |
| Dec 3, 2025 | Philips North America Llc CT 5300;
Software Version Number: 4.5, 5.0, 5.1; Open, Classified |
JAK | K232491 |
| Dec 3, 2025 | Philips North America Llc Incisive CT;
Software Version Number: 4.5, 5.0, 5.1; Open, Classified |
JAK | K180015 K212441 +1 |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: Incisive CT for Brazil SKD;
Product Code (REF): 728146;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | K180015 K212441 +1 |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: CT 5300;
Product Code (REF): 728285;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | K180015 K212441 +1 |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: Incisive CT;
Product Code (REF): (1) 728143, (2) 728144;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | K180015 K212441 +1 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI Panorama 35
MD, Rx Only Open, Classified |
JAK | K223325 K232712 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI 780
MD, Rx Only Open, Classified |
JAK | K172143 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uMI 550
MD, Rx Only Open, Classified |
JAK | K182237 K193241 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System
Model:uEXPLORER
MD, Rx Only Open, Classified |
JAK | K231762 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT ATLAS
MD, Rx Only Open, Classified |
JAK | K203448 K231482 +1 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 780
MD, Rx Only Open, Classified |
JAK | K172135 K230162 +1 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 760
MD, Rx Only Open, Classified |
JAK | K172135 K230162 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 550
MD, Rx Only Open, Classified |
JAK | K181414 K200016 |
| Oct 21, 2025 | UIH Technologies LLC Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System,
Model:uCT 530
MD, Rx Only Open, Classified |
JAK | K181414 K200016 |
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