510(k) K103476 ยท IZL System, X-Ray, Mobile
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 16, 2011 |
| Received | Nov 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103476
| 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, Brivo XR285amx 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: Brivo XR285amx Terminated |
IZL | None listed |
| Jan 11, 2014 | GE Healthcare, LLC GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. Terminated |
IZL | None listed |
| Aug 9, 2013 | GE Healthcare, LLC GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx.
The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and proc Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.