Pure Global

Radiology picture archiving and communication system application software

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 IIa is sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics LLC in United States of America. The device registration started on September 11, 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 picture archiving and communication system application software
Australia TGA ARTG Registered Device
Good Name: GE Healthcare Australia Pty Ltd - Radiology picture archiving and communication system application software
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Intended Purpose

This device is intended to serve the purposes of electronic documentation (recording) and storage of examinations in the form of text and images. This device is intended to accept, transfer, display, store and process medical images and data, and can measure, calculate, annotate, prepare and print patient examination reports primarily for diagnostic ultrasound.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 11, 2019
Effective Date
September 11, 2019
Manufacturer
Country
United States of America
Address
9900 Innovation Drive, Wauwatosa, WI, 53226