510(k) K212813 ยท OWB Interventional Fluoroscopic X-Ray System
Zenition 70
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Oct 1, 2021 |
| Received | Sep 3, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2025 | Philips North America Llc Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and
surgical procedures on all patients, except neonates (birth to Open, Classified |
OWB | None listed |
| Apr 21, 2025 | Philips Medical Systems Nederland B.V. Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Open, Classified |
OWB | None listed |
| Nov 12, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Zenition 70, Model Number: 718133 Open, Classified |
OWB | None listed |
| Sep 30, 2024 | Philips North America Zenition 50 & 70 Mobile Surgery C-arm Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.