510(k) K132147 ยท OWB Interventional Fluoroscopic X-Ray System
2D PERFUSION
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Dec 16, 2013 |
| Received | Jul 11, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K132147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2023 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.