# K203346: OEC 3D

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems, Inc.
- Decided: Mar 5, 2021 after 112 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K021049 (2002). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192819: OEC Elite, Ge Oec Medical Systems, Inc. (2019) Summary page 4.

## Most influential descendants
- K233669: OEC 3D (2024), 0 descendants of its own

## Recalls of this device
- Mar 21, 2025 · Class II · Z-1820-2025: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- Nov 21, 2024 · Class II · Z-0703-2025: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
- Jun 10, 2021 · Class II · Z-2160-2021: There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

## Indications for use
The OEC 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency procedures.

Source page: https://510kreport.com/device/K203346
Methodology: https://510kreport.com/methodology