Australia TGA ARTG record

Hyperthermia system, ultrasound

Australia TGA ARTG Registered Device · GE Healthcare Australia Pty Ltd · InSightec Ltd · Class IIb · Started May 19, 2006

Good Name: GE Medical Systems Australia Pty Ltd - Hyperthermia system, ultrasound

Device classification

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

Registration information

Start Date: May 19, 2006
Effective Date: May 19, 2006

Sponsor

Name: GE Healthcare Australia Pty Ltd

Manufacturer

Name: InSightec Ltd
Country: Israel
Address: 5 Nachum Chet Street, Tirat Carmel, 39120

Intended purpose

This system is intended to be used to produce and control the delivery of high heat, ie temperatures greater than 43 degrees Celsius, to the body for the treatment of malignant or benign tumours, or other disease conditions. It is typically computer controlled and it intended to be capable of producing whole body or localized heating effects within tissue or organs using an ultrasonic energy source.

About this record

Access comprehensive regulatory information for Hyperthermia system, ultrasound in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by GE Healthcare Australia Pty Ltd, manufactured by InSightec Ltd in Israel. The device registration started on May 19, 2006.

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.