510(k) K171850 ยท JAK System, X-Ray, Tomography, Computed
Philips CT Big Bore
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 9, 2017 |
| Received | Jun 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171850
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| Nov 14, 2023 | Philips North America Llc Big Bore RT with software version V4.8.0.10421- Model: 728242
CT scanner and simulator designed for radiation oncology and therapy. Open, Classified |
JAK | None listed |
| Nov 14, 2023 | Philips North America Llc Brilliance CT Big Bore with software version V4.8.0.10421
Model:728244
CT scanner and simulator designed for radiation oncology and therapy. Open, Classified |
JAK | None listed |
| Nov 14, 2023 | Philips North America Llc Brilliance CT Big Bore Oncology with software version V4.8.0.10421
Model:728243
CT scanner and simulator designed for radiation oncology and therapy. Open, Classified |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstru Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance 64 (Model No. 728231), Software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray tr Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance iCT (Model No. 728306), Software Version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray t Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstr Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity CT (Model No. 728326), software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray tra Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity Core (Model No. 728321), Software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray t Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 (Model No. 728323), Software version 4.1.6
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-r Terminated |
JAK | None listed |
| Jun 7, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.