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MR Imaging System - MRI system, full-body, permanent magnet - ARTG 464227

Access comprehensive regulatory information for MR Imaging System - MRI system, full-body, permanent magnet in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 464227 and sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Corporation in Japan. The device registration started on October 14, 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 IIa
ARTG 464227
Class IIa
MR Imaging System - MRI system, full-body, permanent magnet
ARTG ID: 464227
Good Name: Fujifilm Australia Pty Ltd - MR Imaging System - MRI system, full-body, permanent magnet
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Intended Purpose

This device applies the radio-frequency magnetic field to the patient in magnetic field and receives energy emitted when protons caused nuclear magnetic resonance return to their original state, and reconstructs tomograms of various regions of human body through computer processing.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
464227
Start Date
October 14, 2024
Effective Date
October 14, 2024
Manufacturer
Country
Japan
Address
26-30 Nishiazabu 2 Chome, MINATO KU TOKYO, 106 8620