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Radiology picture archiving and communication system application software - ARTG 465788

Access comprehensive regulatory information for Radiology picture archiving and communication 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 465788 and sponsored by Hologic (Australia & New Zealand) Pty Ltd, manufactured by Hologic Inc in United States of America. The device registration started on October 24, 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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Class IIb
ARTG 465788
Class IIb
Radiology picture archiving and communication system application software
ARTG ID: 465788
Good Name: Hologic (Australia & New Zealand) Pty Ltd - Radiology picture archiving and communication system application software
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Intended Purpose

The device may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465788
Start Date
October 24, 2024
Effective Date
October 24, 2024
Manufacturer
Country
United States of America
Address
600 Technology Drive, Newark, Delaware, 19702