510(k) K041932 ยท OWB Interventional Fluoroscopic X-Ray System
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
| Applicant | Ge Oec Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Aug 18, 2004 |
| Received | Jul 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041932
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2012 | GE OEC Medical Systems, Inc GEHC OEC Injection Cable for MedRad Provis V Contrast Injector.
In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers i Terminated |
OXO | None listed |
| Aug 22, 2012 | GE OEC Medical Systems, Inc GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as Terminated |
OXO | None listed |
| Jul 18, 2012 | GE OEC Medical Systems, Inc OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures.
The system is an aid to lo Terminated |
JAA | None listed |
| Sep 1, 2008 | OEC Medical Systems, Inc OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT. Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
| Sep 28, 2007 | GE OEC Medical Systems, Inc OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.