Device Dossier

X-ray image interpretive software

Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIb, sponsor Hologic (Australia & New Zealand)). ARTG…

Intended purpose

The Image Analytics family includes software which aids radiologists in the interpretation of mammographic images. It is not intended to be a sole or primary diagnosis tool; and it is not intended to replace skills and expertise of radiologists.

TGA Public Summary