Stereotactic system application software - ARTG 472785
Access comprehensive regulatory information for Stereotactic system application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 472785 and sponsored by Hologic (Australia & New Zealand) Pty Ltd, manufactured by Hologic Inc in United States of America. The device registration started on December 12, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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).