510(k) K183101 ยท OWB Interventional Fluoroscopic X-Ray System
Zenition 50
| Applicant | Philips Medical Systems Nederland B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Dec 31, 2018 |
| Received | Nov 7, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K183101
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Zenition 50;
Product Number (REF): 718096; Interventional fluoroscopic x-ray system Open, Classified |
OWB | None listed |
| Apr 21, 2025 | Philips North America Llc Zenition 50. Product Code 718096.
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 |
| Nov 12, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Zenition 50, Model Number: 718096 Open, Classified |
OWB | None listed |
| Sep 30, 2024 | Philips North America Zenition 50 & 70 Mobile Surgery C-arm Open, Classified |
OWB | None listed |
| Dec 2, 2021 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Zenition 50, Model #718096 Open, Classified |
OWB | None listed |
| Apr 10, 2020 | Philips North America, LLC Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, exc Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.