Device Dossier

Stereotactic biopsy system, diagnostic x-ray, mammography

Device Dossier for Stereotactic biopsy system, diagnostic x-ray, mammography (Stereotactic biopsy system, diagnostic x-ray, mammography, Class IIa,…

Intended purpose

The Breast Biopsy System is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

TGA Public Summary