510(k) K163711 ยท JAK System, X-Ray, Tomography, Computed
IQon Spectral CT
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | Dec 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163711
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. IQon Spectral CT, Model Number: 728332. Open, Classified |
JAK | None listed |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT
Model # 728332, computed tomography x-ray system Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.