510(k) K211168 ยท JAK System, X-Ray, Tomography, Computed
Philips Incisive CT on Trailer
| Applicant | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Nov 22, 2021 |
| Received | Apr 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211168
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2023 | Philips Healthcare Incisive CT, software version 5.0 Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.