510(k) K142383 ยท IZL System, X-Ray, Mobile
Optima XR200amx, Optima XR220amx
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 25, 2014 |
| Received | Aug 26, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2026 | GE Medical Systems, LLC Optima XR200amx, Mobile Digital-Ready Radiographic System Open, Classified |
IZL | None listed |
| Jul 13, 2026 | GE Medical Systems, LLC Optima XR220amx, Mobile Digital-Ready Radiographic System Open, Classified |
IZL | None listed |
| Jan 7, 2025 | GE Medical Systems, LLC GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-3;
2) 5555000-4:
3) A0659MB Open, Classified |
IZL | None listed |
| Jan 7, 2025 | GE Medical Systems, LLC GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-12;
2) 5555000-5;
3) 5555000-6;
4) A0659PB;
5) to be provided Open, Classified |
IZL | None listed |
| Feb 8, 2016 | GE Medical Systems, LLC GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System
Designed to generate diagnostic radiographic images. Terminated |
IZL | None listed |
| Feb 8, 2016 | GE Medical Systems, LLC GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System
Designed to generate diagnostic radiographic images. Terminated |
IZL | None listed |
| Apr 27, 2015 | GE Healthcare GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx Terminated |
IZL | None listed |
| Apr 27, 2015 | GE Healthcare GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.