Device Dossier

X-ray system, diagnostic, mammographic, accessory, stereotactic unit

Device Dossier for X-ray system, diagnostic, mammographic, accessory, stereotactic unit (X-ray system, diagnostic, mammographic, accessory, stereotactic…

Intended purpose

A device 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 localisation or treatment devices).

TGA Public Summary