# K013426: Moonray Mobile C-Arm

- Pathway: 510(k) (Traditional)
- Applicant: Simad S.R.L.
- Decided: Mar 26, 2002 after 161 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Pathfinder Mobile C-Arm is intended to be used for routine radiography and follow-up x-rays such as (e.g. gastrointestinal studies, chest, bone, hip pinning and pacemaker implants).

Source page: https://510kreport.com/device/K013426
Methodology: https://510kreport.com/methodology