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MRI system, application program software - ARTG 399232

Access comprehensive regulatory information for MRI system, 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 399232 and sponsored by Siemens Healthcare Pty Ltd, manufactured by Circle Cardiovascular Imaging Inc in Canada. The device registration started on November 11, 2022.

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 IIa
ARTG 399232
Class IIa
MRI system, application program software
ARTG ID: 399232
Good Name: Siemens Healthcare Pty Ltd - MRI system, application program software
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399232
Start Date
November 11, 2022
Effective Date
November 11, 2022
Manufacturer
Country
Canada
Address
Suite 1100 800 5th Avenue SW, Calgary, Alberta, T2P 3T6