# K242019: GXR-Series Diagnostic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: DRGEM Corporation
- Decided: Jan 7, 2025 after 181 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 K981556 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202572: GXR-Series Diagnostic X-Ray System, DRGEM Corporation (2020) Summary page 5.

## Indications for use
The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.

Source page: https://510kreport.com/device/K242019
Methodology: https://510kreport.com/methodology