ARTG 446950Synchronizer, MRI system
ARTG ID: 446950 · GE Healthcare Australia Pty Ltd · IVY Biomedical Systems Inc · Class I · Started April 29, 2024
Good Name: GE Healthcare Australia Pty Ltd - Synchronizer, MRI system
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 446950
- Start Date
- April 29, 2024
- Effective Date
- April 29, 2024
- Country
- United States of America
- Address
- 11 Business Park Drive, BRANFORD, Connecticut, 06405
The Ivy MR Wireless Gating System’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.
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.