Device Dossier

X-ray system, diagnostic, computed tomography, full-body

Device Dossier for X-ray system, diagnostic, computed tomography, full-body (X-ray system, diagnostic, computed tomography, full-body, Class IIb, sponsor…

Intended purpose

This medical device is a diagnostic x-ray computed tomography (CT) system with a gantry large enough intended to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area.

TGA Public Summary