# K132921: Galaxy Plus

- Pathway: 510(k) (Traditional)
- Applicant: Medien International Co, Ltd.
- Decided: Jan 17, 2014 after 122 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K981556 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102408: Digital Diagnostic X-Ray System, DRGEM Corporation (2010) Summary page 1.

## Indications for use
The Galaxy Plus Digital Radiography System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K132921
Methodology: https://510kreport.com/methodology