Device Dossier

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

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

Intended purpose

A self-contained battery operated mobile radiographic digital imaging system designed for performing radiographic exams at the point of care when it is not safe or practical to move the patient to the radiographic room. The device is suited for routine radiographic procedures within a hospital including radiology departments, intensive care units, cardiac care units, emergency departments, operating rooms, orthopedics, pediatrics, hospital rooms and clinics.

TGA Public Summary