ARTG 472785Stereotactic system application software
ARTG ID: 472785 · Hologic (Australia & New Zealand) Pty Ltd · Hologic Inc · Class IIb · Started December 12, 2024
Good Name: Hologic (Australia & New Zealand) Pty Ltd - Stereotactic system application software
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 472785
- Start Date
- December 12, 2024
- Effective Date
- December 12, 2024
- Name
- Hologic Inc
- Country
- United States of America
- Address
- 600 Technology Drive, Newark, Delaware, 19702
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).
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.