# K181943: OSCAR (OSCAR Prime, OSCAR Classic)

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Aug 17, 2018 after 28 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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 K010435 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091918: Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro, Genoray Co., Ltd. (2009) Summary page 5.

## Most influential descendants
- K252229: Belliger Ace (2026), 0 descendants of its own

## Indications for use
OSCAR is a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic. vascular, and stone localization.

Source page: https://510kreport.com/device/K181943
Methodology: https://510kreport.com/methodology