# K160131: OEC Elite MiniView

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hangwei Medical Systems Co., Ltd.
- Decided: Jun 21, 2016 after 153 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: 1 generation back to K992506 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992506: Mini 6800 Digital Mobile C-Arm, Ge Dec Medical Systems (1999) Summary page 5.

## Most influential descendants
- K171800: OEC Elite MiniView (2017), 0 descendants of its own

## 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/K160131
Methodology: https://510kreport.com/methodology