TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
DRGEM CorporationThe TOPAZ Mobile X-ray System by DRGEM Corporation is a portable X-ray machine designed to obtain high-quality digital radiographic images for patients who cannot be moved to the radiology department. It features a motorized drive mechanism for easy mobility, a flat panel digital detector for rapid image acquisition, and enhanced software for image processing. The system supports various flat panel detectors and includes a touchscreen interface to facilitate workflow, helping clinicians quickly and accurately examine patients in bed or other immobile settings.
Intended Use
The ‘TOPAZ Mobile X-ray System’ is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.
Technology
The system consists of a tube assembly, motorized x-ray collimator, high voltage x-ray generator, touchscreen LCD control console, and digital flat panel detector using CsI scintillator for high resolution and stability. The RADMAX software processes the radiological images to improve workflow and image quality. The system supports multiple flat panel detector models and has a collapsible column stand option for easier maneuverability.
Performance
The device underwent extensive nonclinical validation including electrical safety, EMC, software verification and validation, and risk analysis per international standards (IEC 60601 series, ISO 14971, IEC 62304). Verification confirmed the device is as safe and effective as its predicate device with no new safety concerns. Cybersecurity measures were also implemented and tested. The addition of new flat panel detectors and software updates showed no negative impact on safety or effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/10/2024
5 months - 2
FDA Approval
12/16/2024
Other devices from DRGEM Corporation
- GXR-Series Diagnostic X-Ray System2025 • 510K
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