510(k) K201640 ยท KPR System, X-Ray, Stationary
DuraDiagnost
| Applicant | Philips Healthcare (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jul 9, 2020 |
| Received | Jun 16, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2025 | Philips North America Llc Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. Open, Classified |
KPR | None listed |
| Apr 11, 2025 | Philips North America Llc Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. Open, Classified |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.