# K093816: Digital Radiography System, Models Galaxy 900 and 1600

- Pathway: 510(k) (Traditional)
- Applicant: Medien International Co, Ltd.
- Decided: Oct 5, 2010 after 298 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 2 generations back to K974863 (1998). 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)
- K061595: Xaminer, Imaging Dynamics Company, Ltd. (2006) Summary page 1.
- K992955: Xplorer 1000, Imaging Dynamics Corp. (2000) Summary page 4.

## Indications for use
The Galaxy 900 is integrated into the users stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sifting, standing or lying in the prone or supine positions in an integrated system. The Galaxy 900 is not intended for mammography.

Source page: https://510kreport.com/device/K093816
Methodology: https://510kreport.com/methodology