# K053279: Urovantage

- Pathway: 510(k) (Special)
- Applicant: Pck Electronic Industry & Trade Co., Ltd.
- Decided: Dec 22, 2005 after 29 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 K940295 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011311: Urologic, Pck Electronic Industry and Trade Co, Ltd. (2001) Summary page 1.

## Indications for use
The UroVantage is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to Urologic and endoscopic procedures. The system may be used for other imaging applications at physician’s discretion

Source page: https://510kreport.com/device/K053279
Methodology: https://510kreport.com/methodology