Device Dossier

X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital

Device Dossier for X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital (X-ray system, diagnostic, fluoroscopic, general-purpose,…

Intended purpose

The device is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, peripheral vascular, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography.

TGA Public Summary