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) |
|---|---|---|---|
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. CT 6000, Model Number: 728307. Open, Classified |
JAK | K033326 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Ingenuity CT Family Brazil, Model Number: 728325. Open, Classified |
JAK | K033326 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Ingenuity Core128 / Elite China, Model Number: 728324. Open, Classified |
JAK | K033326 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. IQon Spectral CT, Model Number: 728332. Open, Classified |
JAK | K163711 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Ingenuity CT 728326, Model Number: 728321.
2. Ingenuity CT 728326, Model Number: 728323.
3. Ingenuity CT, Model Number: 728326. Open, Classified |
JAK | K160743 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance iCT SP, Model Number: 728311. Open, Classified |
JAK | K060937 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance iCT, Model Number: 728306. Open, Classified |
JAK | K162838 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Big Bore RT, Model Number: 728242.
2. Brilliance CT Big Bore Oncology, Model Number: 728243.
3. Brilliance CT Big Bore, Model Number: 728244. Open, Classified |
JAK | K171850 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance 16 Power, Model Number: 728240.
2. Brilliance CT 16 Slice, Model Number: 728246.
3. Brilliance CT 6 Slice, Model Number: 728256. Open, Classified |
JAK | K012009 |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance CT 40 Channel, Model Number: 728235.
2. Brilliance CT 64 Channel, Model Number: 728231.
3. Ingenuity Flex, Model Number: 728317 Open, Classified |
JAK | K033326 |
| Jun 26, 2025 | Philips North America Llc Spectral CT. Computed tomography X-ray system. Open, Classified |
JAK | K203020 |
| Jun 9, 2025 | QUANTUM SURGICAL SAS EPIONE Model 30-0001
UDI-DI code: 03760305400031
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, a Open, Classified |
JAK | K223758 |
| Apr 23, 2025 | Philips North America Llc Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. Open, Classified |
JAK | K171850 |
| Mar 12, 2025 | Philips Medical Systems Nederland B.V. Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; Open, Classified |
JAK | K212875 |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed Open, Classified |
JAK | K163213 K191777 +1 |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution CT, System, X-ray, Tomography, Computed Open, Classified |
JAK | None listed |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed Open, Classified |
JAK | K213715 |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed Open, Classified |
JAK | K191777 K213715 |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed Open, Classified |
JAK | None listed |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed Open, Classified |
JAK | K213715 |
| Mar 7, 2025 | GE Medical Systems, LLC GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed Open, Classified |
JAK | K163213 K191777 +1 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA:
China Only: Discovery CT750HD Open, Classified |
JAK | K081105 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA:
China Only: Revolution Discovery CT Open, Classified |
JAK | K081105 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA:
EU: Operator Console (for BrightSpeed,
Elite/BrightSpeed Elite Select),
Non-EU: BrightSpeed Elite, BrightSpeed
Elite Open, Classified |
JAK | K052855 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA:
EU: RT Refresh Package,
Non-EU: Discovery RT, Optima CT580, or
Discovery CT590 RT; X-ray/computed tomography system Open, Classified |
JAK | K093581 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system Open, Classified |
JAK | K192686 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system Open, Classified |
JAK | K192686 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Maxima, Model Numbers:
1) 6665000-2,
2) 6670000-2,
3) 6670000-200,
4) 6670000-6; X-ray/computed tomography system Open, Classified |
JAK | K192686 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system Open, Classified |
JAK | K120833 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system Open, Classified |
JAK | K131576 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system Open, Classified |
JAK | K192686 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system Open, Classified |
JAK | K213938 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems Open, Classified |
JAK | K123596 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems Open, Classified |
JAK | K192686 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system Open, Classified |
JAK | None listed |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems Open, Classified |
JAK | K123596 |
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as: Open, Classified |
JAK | K093581 |
| Dec 3, 2024 | Philips North America Llc Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. Open, Classified |
JAK | K203020 |
| Dec 2, 2024 | Orthoscan, Inc. Ziehm Vision system, x-ray, tomography, computed. Open, Classified |
JAK | K073346 |
| Oct 9, 2024 | QUANTUM SURGICAL SAS The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrum Completed |
JAK | K223758 |
| May 20, 2024 | Philips North America Llc Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body.
Model Number: 728144 Open, Classified |
JAK | K212441 |
| May 20, 2024 | Philips North America Llc Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body.
Model Number: 728143 Open, Classified |
JAK | K180015 |
| May 2, 2024 | Philips North America Llc The Oncology Essentials Package of the Spectral CT imaging system. Open, Classified |
JAK | K203020 |
| Apr 9, 2024 | Philips North America PHILIPS Incisive Computed tomography X-ray system
Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body
Model Number: 728143 Open, Classified |
JAK | K180015 |
| Feb 8, 2024 | PHILIPS MEDICAL SYSTEMS Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340. Open, Classified |
JAK | K203020 |
| Feb 8, 2024 | PHILIPS MEDICAL SYSTEMS Spectral CT on Rails: Software Version 5.1.0.X, model 728334. Open, Classified |
JAK | K212875 |
| Jan 12, 2024 | Philips North America Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System
PIM cable part number 459801179871 Open, Classified |
JAK | K180015 K212441 |
| Jan 12, 2024 | Philips North America Llc Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. Open, Classified |
JAK | K203020 |
| Jan 5, 2024 | Philips Healthcare (Suzhou) Co., Ltd. Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Open, Classified |
JAK | K180015 K212441 |
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