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Hyperthermia system, ultrasound

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.

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Class IIb
Class IIb
Hyperthermia system, ultrasound
Australia TGA ARTG Registered Device
Good Name: GE Medical Systems Australia Pty Ltd - Hyperthermia system, ultrasound
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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.

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
Manufacturer
Country
Israel
Address
5 Nachum Chet Street, Tirat Carmel, 39120