Australia flagARTG 464965

X-ray image interpretive software

ARTG ID: 464965 · Hologic (Australia & New Zealand) Pty Ltd · Hologic Inc · Class IIb · Started October 19, 2024

Good Name: Hologic (Australia & New Zealand) Pty Ltd - X-ray image interpretive software

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
464965
Start Date
October 19, 2024
Effective Date
October 19, 2024
Sponsor
Manufacturer
Country
United States of America
Address
600 Technology Drive, Newark, Delaware, 19702
Intended purpose

The Image Analytics family includes software which aids radiologists in the interpretation of mammographic images. It is not intended to be a sole or primary diagnosis tool; and it is not intended to replace skills and expertise of radiologists.

About this record

Access comprehensive regulatory information for X-ray image interpretive software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 464965 and sponsored by Hologic (Australia & New Zealand) Pty Ltd, manufactured by Hologic Inc in United States of America. The device registration started on October 19, 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.

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