# K121303: Mobile C-Arm

- Pathway: 510(k) (Traditional)
- Applicant: Canon Inc. -Medical Equipment Group
- Decided: Jul 26, 2012 after 86 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- 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: 11 generations back to K890348 (1989). 88 ancestors in all.
No later device cites it as a predicate yet.
1 of 89 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090590: Veradius, Model 718-130, Philips Medical Systems North America Co. (2009) Summary page 1.
- K021049: Oec 9800 Plus Digital Mobile Imaging System, Ge Oec Medical Systems (2002) Summary page 1.
- K093688: Canon, Model Urs-50RF, Virtual Imaging, Inc. (2010) Summary page 1.
- K111824: Flat Panel Detector, Canon Inc. -Medical Equipment Group (2012) Summary page 1.

## Indications for use
The XEPHILIO MC- 100 mobile fluoroscopy system is designed to provide fluoroscopic and spot-film radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiograpby, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be usedfor other imaging applicationsat the physician's discretion.

Source page: https://510kreport.com/device/K121303
Methodology: https://510kreport.com/methodology