Australia TGA ARTG record

MRI system - MRI system, full-body, permanent magnet

Australia TGA ARTG Registered Device · Fujifilm Australia Pty Ltd · FUJIFILM Healthcare Corporation · Class IIa · Started October 13, 2023

Good Name: Fujifilm Australia Pty Ltd - MRI system - MRI system, full-body, permanent magnet

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: October 13, 2023
Effective Date: October 13, 2023

Sponsor

Name: Fujifilm Australia Pty Ltd

Manufacturer

Name: FUJIFILM Healthcare Corporation
Country: Japan
Address: 2-1 Shintoyofuta Kashiwa-shi, Chiba, 277-0804

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.

About this record

Access comprehensive regulatory information for MRI 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 sponsored by Fujifilm Australia Pty Ltd, manufactured by FUJIFILM Healthcare Corporation in Japan. The device registration started on October 13, 2023.

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.