# K050866: Centrion 500 C-Arm System

- Pathway: 510(k) (Traditional)
- Applicant: Osteosys Co.,Ltd
- Decided: Apr 27, 2005 after 22 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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 K003837 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003837: Flexiview 8800 Digital Mobile Imaging System, Ge Oec Medical Systems (2001) Summary page 1.

## Indications for use
The Centrion 500 C-Arm System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic and surgical procedures. Clinical applications include, but are not limited to, general surgery, gastro-intestinal, urologic, orthopedic,neurologic, vascular, and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Source page: https://510kreport.com/device/K050866
Methodology: https://510kreport.com/methodology