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Radiology Workstation Software - Radiology picture archiving and communication system application software

Access comprehensive regulatory information for Radiology Workstation Software - 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 IIa is sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Healthcare Americas Corporation in United States of America. The device registration started on June 25, 2019.

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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TGA ARTG Official Data
Class IIa
Class IIa
Radiology Workstation Software - Radiology picture archiving and communication system application software
Australia TGA ARTG Registered Device
Good Name: Fujifilm Australia Pty Ltd - Radiology Workstation Software - Radiology picture archiving and communication system application software
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Intended Purpose

An application or operating data program designed for use in, or together with a, picture archiving and communication system (PACS) so that this may function according to its intended purpose. This software program may be permanently installed or exchanged as an upgrade.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
June 25, 2019
Effective Date
June 25, 2019
Manufacturer
Country
United States of America
Address
81 Hartwell Avenue Suite 300 Lexington, Massachusetts, 02421