# K240828: OEC One ASD

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hualun Medical Systems Co., Ltd.
- Decided: Dec 27, 2024 after 276 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: 8 generations back to K021049 (2002). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182626: OEC One, Ge Hualun Medical Systems Co., Ltd. (2018) Summary page 7.

## Most influential descendants
- K253269: OEC One CFD (2025), 0 descendants of its own

## Indications for use
The OEC One ASD mobile C-arm system 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/K240828
Methodology: https://510kreport.com/methodology