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 digital general-purpose mobile diagnostic x-ray system intended for use in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded, by the addition of hardware/software components. It does not possess fluoroscopic or tomographic capabilities.

TGA Public Summary