510(k) K082781 ยท OWB Interventional Fluoroscopic X-Ray System
OEC 9900 ELITE
| Applicant | Ge Healthcare Surgery, Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Sep 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082781
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2025 | GE Medical Systems, LLC GE HealthCare OEC 9900 Elite C-arm Systems. Open, Classified |
OWB | None listed |
| Dec 18, 2024 | GE OEC Medical Systems, Inc OEC 9900 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnost Open, Classified |
OXO | None listed |
| Jul 31, 2023 | GE OEC Medical Systems, Inc OEC 9900 Systems with 9-inch Image Intensifier Open, Classified |
OXO | None listed |
| Apr 16, 2014 | GE OEC Medical Systems, Inc The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventiona Terminated |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.