Device Dossier

X-ray image interpretive software

Device Dossier for X-ray image interpretive software (X-ray image interpretive software, Class IIa, sponsor AA-Med). ARTG record, intended purpose, GMDN…

Intended purpose

Lunit INSIGHT MMG is a Computer-Assisted Detection/Diagnosis (CAD) software device that assists interpreting physicians in the interpretation of mammograms. The device has been designed to automatically analyze digital mammograms via deep learning technology.

TGA Public Summary