510(k) K233669 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 28, 2024 |
| Received | Nov 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233669
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.