510(k) K010762 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
PHILIPS BV LIBRA
| Applicant | Philips Medical Systems, Inc., Da Best, NL |
| Decision | Substantially Equivalent, Apr 2, 2001 |
| Received | Mar 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Libra, Mobile X-ray unit, 718022.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic
techniques in a wide variety surgical and non-surgical applications including; cerebral, Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.