510(k) K254186 ยท OWB Interventional Fluoroscopic X-Ray System
Azurion R3.1
| Applicant | Philips Medical Systems B.V., Best, NL |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Dec 23, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254186
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.