510(k) K233945 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
ProxiDiagnost N90 / Precision CRF (706110, 706400)
| Applicant | Philips Medical Systems Dmc GmbH, Hamburg, DE |
| Decision | Substantially Equivalent, Jan 11, 2024 |
| Received | Dec 14, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Philips Medical Systems DMC GmbH ProxiDiagnost N90;
Model Number: 706110; Open, Classified |
JAA | None listed |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH Precision CRF;
Model Number: 706400; Open, Classified |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.