510(k) K203346 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
OEC 3D
| Applicant | Ge Oec Medical Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 5, 2021 |
| Received | Nov 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2025 | GE Medical Systems, LLC OEC 3D Open, Classified |
OXO | None listed |
| Dec 18, 2024 | GE OEC Medical Systems, Inc OEC 3D REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is Open, Classified |
OXO | None listed |
| Jun 10, 2021 | GE OEC Medical Systems, Inc OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, inte Terminated |
OXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.