OEC 3D— 510(k) K203346
Substantially EquivalentGe Oec Medical Systems, Inc.
FDA 510(k) clearance K203346 for OEC 3D, Substantially Equivalent on 2021-03-05. 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 K203346
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.
- Z-2160-2021 — 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, interventional, and surgical procedures
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203346.
Data sourced from openFDA. This site is unofficial and independent of the FDA.