Device type
System, X-Ray, Tomography, Computed
Product code JAK · Class II · 21 CFR 892.1750 · Radiology
Recent 510(k)s
Oct 16, 2026
K260391
AVIEW Aorta Metrics
Coreline Soft Co., Ltd.
- JAK
- Class II
Sep 29, 2026
K261225
CAS-One IR
Cascination AG
- JAK
- Class II
Sep 22, 2026
K261125
BodyTom 64 (NL4100); OmniTom Elite (NL5000)
Samsung HME America, Inc., dba NeuroLogica Corp.
- JAK
- Class II
Sep 18, 2026
K261229
SCENARIA View Phase 6.0
Fujifilm Corporation
- JAK
- Class II
Sep 4, 2026
K253836
FCT iStream Phase 2
Fujifilm Corporation
- JAK
- Class II
Recent recalls
Oct 14, 2026
Z-0078-2027
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…
PHILIPS MEDICAL SYSTEMS
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3279-2026
Computed Tomography X-ray System, Model: uCT 760 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3278-2026
Computed Tomography X-ray System, Model: uCT 550 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3280-2026
Computed Tomography X-ray System, Model: uCT 780 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3155-2026
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Philips North America Llc
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3281-2026
Computed Tomography X-ray System, Model: uCT ATLAS with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3282-2026
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3277-2026
Computed Tomography X-ray System, Model: uCT 530 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Sep 9, 2026
Z-3041-2026
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Philips North America Llc
- JAK
- Class II
- Ongoing
Sep 9, 2026
Z-3040-2026
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Philips North America Llc
- JAK
- Class II
- Ongoing
Sep 9, 2026
Z-3043-2026
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Philips North America Llc
- JAK
- Class II
- Ongoing
Sep 9, 2026
Z-3042-2026
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Philips North America Llc
- JAK
- Class II
- Ongoing
Sep 2, 2026
Z-2988-2026
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Philips Healthcare (Suzhou) Co., Ltd.
- JAK
- Class II
- Ongoing