510(k) K182234 ยท IZL System, X-Ray, Mobile
Optima XR240amx
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 6, 2018 |
| Received | Aug 17, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2026 | GE Medical Systems, LLC Optima XR240amx, Mobile Digital Radiographic System Open, Classified |
IZL | None listed |
| Jan 7, 2025 | GE Medical Systems, LLC GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-27;
2) 5555000-31;
3) 5555000-33;
4) 5555000-41;
5) 5555000-47;
6) A0700DL;
7) A1700DA;
8) To be p Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.