# K171800: OEC Elite MiniView

- Pathway: 510(k) (Special)
- Applicant: Ge Hualun Medical Systems Co., Ltd.
- Decided: Jul 12, 2017 after 26 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: 2 generations back to K992506 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160131: OEC Elite MiniView, Ge Hangwei Medical Systems Co., Ltd. (2016) Summary page 4.

## Indications for use
The OEC Elite MiniView (mobile mini C-Arm) is designed to provide physicians with real time general fluoroscopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.

Source page: https://510kreport.com/device/K171800
Methodology: https://510kreport.com/methodology