# K150663: Diagnostic X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Osko, Inc.
- Decided: May 7, 2015 after 52 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: 10 generations back to K801623 (1980). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121513: Multix Fusion, Siemens Medical Solution (2012) Summary page 4.

## Indications for use
The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. The XR5 diagnostic X-ray system is designed to be used with conventional film/screen, CR cassettes or digital detectors. NOT intended for Mammography use.

Source page: https://510kreport.com/device/K150663
Methodology: https://510kreport.com/methodology