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X-ray system, diagnostic, computed tomography, application program software - ARTG 319041

Access comprehensive regulatory information for X-ray system, diagnostic, computed tomography, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 319041 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by Circle Cardiovascular Imaging Inc in Canada. The device registration started on June 18, 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
ARTG 319041
Class IIa
X-ray system, diagnostic, computed tomography, application program software
ARTG ID: 319041
Good Name: GE Healthcare Australia Pty Ltd - X-ray system, diagnostic, computed tomography, application program software
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Intended Purpose

This device is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images and cardiovascular computed tomography (CT) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
319041
Start Date
June 18, 2019
Effective Date
June 18, 2019
Manufacturer
Country
Canada
Address
Suite 1100 800 5th Avenue SW, Calgary, Alberta, T2P 3T6