510(k) K210982 ยท IZL System, X-Ray, Mobile
AMX Navigate
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 28, 2021 |
| Received | Apr 1, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210982
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2021 | GE Healthcare, LLC AMX Navigate Mobile X-Ray System Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.