510(k) K052897 ยท IZL System, X-Ray, Mobile
GE DEFINIUM AMX 700, MODEL AMX 700
| Applicant | General Electric Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 8, 2005 |
| Received | Oct 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052897
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2007 | GE Medical Systems LLC Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.