# K121854: System, X-Ray, Stationary

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sinopharm Hundric Mediline Info. Tech. Co.
- Decided: Aug 22, 2012 after 58 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: 4 generations back to K862120 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012389: Revolution XR/D Digital Radiographic Imaging System, Ge Medical Systems, Inc. (2001) Summary page 2.

## Indications for use
The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K121854
Methodology: https://510kreport.com/methodology