510(k) K974355 ยท OWB Interventional Fluoroscopic X-Ray System
INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
| Applicant | Ge Dec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 17, 1998 |
| Received | Nov 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2016 | GE OEC Medical Systems, Inc OEC 9800, fluoroscopic x-ray system Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.