# K121444: Flat Panel Detector

- Pathway: 510(k) (Special)
- Applicant: Canon, Inc. - Medical Equpment Group
- Decided: Jun 7, 2012 after 23 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: 1 generation back to K111824 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111824: Flat Panel Detector, Canon Inc. -Medical Equipment Group (2012)

## Indications for use
The flat panel detector CSX-20 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventiozial procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures or other-imaging applications at the physician's discretion. The device is intended to replace the spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifer technology. Not intendbdfor mammography applications.

Source page: https://510kreport.com/device/K121444
Methodology: https://510kreport.com/methodology