Australia TGA ARTG record

Ultrasound system, imaging, general-purpose

Australia TGA ARTG Registered Device · GE Healthcare Australia Pty Ltd · GE Medical Systems Ultrasound and Primary Care Diagnostics LLC · Class IIa · Started December 01, 2014

Good Name: GE Healthcare Australia Pty Ltd - Ultrasound system, imaging, general-purpose

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 01, 2014
Effective Date: December 01, 2014

Sponsor

Name: GE Healthcare Australia Pty Ltd

Manufacturer

Name: GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
Country: United States of America
Address: 9900 Innovation Drive, Wauwatosa, WI, 53226

Intended purpose

This general-purpose diagnostic ultrasound system imaging system is intended exclusively for use in a wide variety of both extracorporeal and/or intracorporeal body imaging procedures. This general purpose system supports a wide variety of transducers and related application software packages allowing for the collection, display and analysis of ultrasound information.

About this record

Access comprehensive regulatory information for Ultrasound system, imaging, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics LLC in United States of America. The device registration started on December 01, 2014.

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.