# K220149: General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)

- Pathway: 510(k) (Traditional)
- Applicant: Xera Medical Systems & Technology, Ltd.
- Decided: Apr 19, 2022 after 90 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: 9 generations back to K801623 (1980). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081722: YSIO, Siemens Medical Solutions USA, Inc. (2008) Summary page 4.

## Indications for use
The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic applications.

Source page: https://510kreport.com/device/K220149
Methodology: https://510kreport.com/methodology