# K163063: UC-5000 Mobile X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Source-Ray, Inc.
- Decided: Dec 12, 2016 after 40 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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 K090655 (2009). 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)
- K090655: Portable X-Ray System, Model Powermax 1260, Source-Ray, Inc. (2009) Summary page 4.

## Indications for use
The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammography.

Source page: https://510kreport.com/device/K163063
Methodology: https://510kreport.com/methodology