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MRI system, full-body, superconducting magnet - ARTG 474969

Access comprehensive regulatory information for MRI system, full-body, superconducting magnet in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 474969 and sponsored by Philips Electronics Australia Ltd, manufactured by Philips Medical Systems Nederland BV in Netherlands. The device registration started on January 03, 2025.

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 I
ARTG 474969
Class I
MRI system, full-body, superconducting magnet
ARTG ID: 474969
Good Name: Philips Electronics Australia Ltd - MRI system, full-body, superconducting magnet
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Intended Purpose

MR scans can be very loud although the level of noise is different for different types of scan methods. (Very) small children will not always tolerate a headset. The acoustic hood is designed to provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations. The Acoustic Hood will provide additional noise damping of around 8 dB (lngenia Acoustic Hood) and 12-14dB (Achieva Acoustic Hood).

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
474969
Start Date
January 03, 2025
Effective Date
January 03, 2025
Manufacturer
Country
Netherlands
Address
Veenpluis 6, Best, 5684 PC