Device Dossier

Stereotactic system application software

Device Dossier for Stereotactic system application software (Stereotactic system application software, Class IIb, sponsor Hologic (Australia & New…

Intended purpose

Affirm Contrast Biopsy is an optional software licence for the Selenia Dimensions 2D full field digital mammography system and the 3Dimension system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

TGA Public Summary