510(k) K936180 ยท OWB Interventional Fluoroscopic X-Ray System
TC+ SYSTEM (TILTING C-ARM SYSTEM)
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 16, 1994 |
| Received | Dec 27, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936180
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2014 | GE Healthcare, LLC Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Presti Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.