# K232178: GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)

- Pathway: 510(k) (Traditional)
- Applicant: DRGEM Corporation
- Decided: Sep 19, 2023 after 57 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 4.

## Indications for use
The “GXR-ES/ECS” System is intended for use in generating radiographic images of human anatomy. The Diagnostic X-ray System consisting of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems. Such as the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position

Source page: https://510kreport.com/device/K232178
Methodology: https://510kreport.com/methodology