510(k) K142708 ยท OWB Interventional Fluoroscopic X-Ray System
VERADIUS UNITY
| Applicant | Philips Medical Systems Nethrlands BV, Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Oct 22, 2014 |
| Received | Sep 22, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K142708
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2025 | Philips North America Llc Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and
surgical procedures on all patients, except neonates (birth Open, Classified |
OWB | None listed |
| Sep 30, 2024 | Philips North America Veradius Unity Mobile Surgery C-arm Open, Classified |
OWB | None listed |
| Dec 2, 2021 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veradius Unity, Model #718132 Open, Classified |
OWB | None listed |
| Nov 12, 2021 | Philips North America Llc Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. .
Model Number: 718132 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.