OEC 3D— 510(k) K233669
Substantially EquivalentGe Oec Medical Systems, Inc.
FDA 510(k) clearance K233669 for OEC 3D, Substantially Equivalent on 2024-03-28. Applicant: Ge Oec Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Oec Medical Systems, Inc.
- Product code
- Code OXO
- 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 OXO
view allMore clearances from Ge Oec Medical Systems, Inc.
view allAdverse events under product code OXO
product code OXO- Death
- 6
- Injury
- 163
- Malfunction
- 2,099
- Other
- 1
- Total
- 2,269
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 K233669
K-number listed on FDA's recall record- Z-1820-2025 — OEC 3D
- Z-0703-2025 — 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 used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233669.
Data sourced from openFDA. This site is unofficial and independent of the FDA.