# K172435: Galaxy R Digital Radiography Upgrade

- Pathway: 510(k) (Traditional)
- Applicant: Medien International Co, Ltd.
- Decided: Oct 13, 2017 after 63 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: 3 generations back to K063710 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113812: ATAL-8, Atlaim (2012) Summary page 4.

## Indications for use
The Galaxy R Digital Radiography Upgrade is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general purpose diagnostic procedures. Not for mammography.

Source page: https://510kreport.com/device/K172435
Methodology: https://510kreport.com/methodology