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 used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

TGA Public Summary