# K253269: OEC One CFD

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hualun Medical Systems Co., Ltd.
- Decided: Nov 26, 2025 after 58 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K021049 (2002). 10 ancestors in all.
No later device cites it as a predicate yet.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240828: OEC One ASD, Ge Hualun Medical Systems Co., Ltd. (2024) Summary page 6.

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

Source page: https://510kreport.com/device/K253269
Methodology: https://510kreport.com/methodology