OEC 9900 ELITE— 510(k) K082781
Substantially EquivalentGe Healthcare Surgery
FDA 510(k) clearance K082781 for OEC 9900 ELITE, Substantially Equivalent on 2009-05-01. Applicant: Ge Healthcare Surgery. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Surgery
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code OWB
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K082781
K-number listed on FDA's recall record- Z-2342-2025 — GE HealthCare OEC 9900 Elite C-arm Systems.
- Z-0705-2025 — 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 diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Z-2277-2023 — OEC 9900 Systems with 9-inch Image Intensifier
- Z-1462-2014 — 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 interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082781.
Data sourced from openFDA. This site is unofficial and independent of the FDA.