# K230787: Oscar 15 & Oscar 15i

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Jul 20, 2023 after 120 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: 6 generations back to K021049 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172180: OSCAR 15, Genoray Co., Ltd. (2018) Summary page 4.

## Indications for use
OSCAR 15 & OSCAR 15i are 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, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion. OSCAR 15 and OSCAR 15i are indicated only for adult patients.

Source page: https://510kreport.com/device/K230787
Methodology: https://510kreport.com/methodology