510(k) K162838 ยท JAK System, X-Ray, Tomography, Computed
Philips iCT CT System
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Oct 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance iCT, Model Number: 728306. Open, Classified |
JAK | None listed |
| Jun 8, 2021 | Philips North America Llc 728306 Brilliance iCT-Computed Tomography X-ray systems
728305 Brilliance iCT Upgrades Terminated |
JAK | None listed |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc iCT,
Model # 728306, computed tomography x-ray system Terminated |
JAK | None listed |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc iCT SP
Model # 728311, computed tomography x-ray system Terminated |
JAK | None listed |
| Jul 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance iCT, 728306
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different Terminated |
JAK | None listed |
| Nov 10, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance iCT
Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.