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Synchronizer, MRI system - ARTG 446950

Access comprehensive regulatory information for Synchronizer, MRI system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 446950 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by IVY Biomedical Systems Inc in United States of America. The device registration started on April 29, 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 I
ARTG 446950
Class I
Synchronizer, MRI system
ARTG ID: 446950
Good Name: GE Healthcare Australia Pty Ltd - Synchronizer, MRI system
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Intended Purpose

The Ivy MR Wireless Gating Systemโ€™s intended use is to acquire physiologic signals, comprising ECG, PP, and respiration, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating up to 3.0 Tesla in strength.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
446950
Start Date
April 29, 2024
Effective Date
April 29, 2024
Manufacturer
Country
United States of America
Address
11 Business Park Drive, BRANFORD, Connecticut, 06405