510(k) K192819 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
OEC Elite
| Applicant | Ge Oec Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 8, 2019 |
| Received | Oct 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2025 | GE Medical Systems, LLC OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, intervent Open, Classified |
OXO | None listed |
| Dec 18, 2024 | GE OEC Medical Systems, Inc OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools Open, Classified |
OXO | None listed |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC Elite Systems with 9-inch Image Intensifier Open, Classified |
OWB | None listed |
| Jun 10, 2021 | GE OEC Medical Systems, Inc OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventi Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.