510(k) K061953 ยท OWB Interventional Fluoroscopic X-Ray System
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
| Applicant | Ge Oec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Aug 15, 2006 |
| Received | Jul 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2014 | GE OEC Medical Systems, Inc The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventiona Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.