GB/T 42061-2022/ISO13485:2016
MDQMS:Design and Manufacture of Portable Digital Medical X-ray System (Picke 1800 DR/100), Digital Mobile Radiography X-ray System (Picke
1900 DRM), Digital Radiography X-ray System (Picke 1800 DR/500, Picke 1800 DR/400), Mobile C-arm X-ray Machine (Picke 2200 DRF),
Fluoroscopy X-ray Machine (Picke 2800 DRF) for Class II medical devices 06-01 diagnostic X-ray machine within the scope of qualification; Design
and Manufacture of X-ray Protection Device(XPS-1) for Class I medical devices 06-06-02 medical radiation protection .