Device Dossier

X-ray system, diagnostic, mammographic, stationary, digital

Device Dossier for X-ray system, diagnostic, mammographic, stationary, digital (X-ray system, diagnostic, mammographic, stationary, digital, Class IIb,…

Intended purpose

This device is a x-ray system specifically intended to compress and image the breast. It is intended to help view and evaluate the anatomy and function of blood and lymphatic vessels within the breast. It uses digital techniques for image capture, display and manipulation, and can display images digitally or can print them. It comprises of the operator work station, the digital image receptor and the X-ray Gantry.

TGA Public Summary