GXR-Series Diagnostic X-Ray System
DRGEM CorporationThe GXR-Series Diagnostic X-Ray System by DRGEM Corporation is a stationary X-ray system designed for medical professionals to capture human anatomical images using X-rays. The system includes various device models with features like automatic calibration, digital flat panel detectors for direct radiography, and advanced image processing software to enhance image quality and workflow efficiency. It helps clinicians by providing high-quality radiographic images for diagnostic purposes while optimizing exposure settings and reducing downtime through remote system diagnosis.
Intended Use
The GXR-Series Diagnostic X-ray System is intended for use in obtaining human anatomical images for medical diagnostic by using X-rays.
Technology
The system consists of an X-ray generator and associated equipment such as tube stands, patient tables, and digital imaging systems. It uses high-frequency X-ray generators with automatic calibration, digital flat panel detectors for direct radiography, and system software for control and image processing (RADMAX). The device also features anatomical programming and optional automatic exposure control, with remote diagnosis software for system maintenance and support.
Performance
Nonclinical testing including validation of input/output functions and software was conducted, meeting predetermined acceptance criteria. The device complies with multiple IEC and ISO standards for electrical safety, EMC, software lifecycle, and medical imaging. No new potential safety or effectiveness risks were identified compared to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/10/2024
6 months - 2
FDA Approval
1/7/2025
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