510(k) K041931 ยท OWB Interventional Fluoroscopic X-Ray System
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
| Applicant | Ge Oec Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Aug 26, 2004 |
| Received | Jul 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2007 | GE OEC Medical Systems, Inc GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Jun 30, 2007 | GE OEC Medical Systems, Inc GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Terminated |
JAA | None listed |
| Oct 25, 2006 | GE OEC Medical Systems, Inc GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc. Terminated |
JAA | None listed |
| Oct 14, 2006 | GE OEC Medical Systems, Inc OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc. Terminated |
JAA | None listed |
| Sep 30, 2006 | GE OEC Medical Systems, Inc GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.