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Hyperthermia system, ultrasound - ARTG 395418

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 IIa is registered under ARTG number 395418 and sponsored by Getz Healthcare Pty Ltd, manufactured by InSightec Ltd in Israel. The device registration started on September 02, 2022.

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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TGA ARTG Official Data
Class IIa
ARTG 395418
Class IIa
Hyperthermia system, ultrasound
ARTG ID: 395418
Good Name: Getz Healthcare Pty Ltd - Hyperthermia system, ultrasound
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Intended Purpose

Accessories to Exablate 4000 System (Type 1.0 and 1.1) that are used for treatment of neurological disorders (Essential Tremors, Tremor Dominant Idiopathic Parkinsonโ€™s Disease โ€“ Unilateral) and Neuropathic Pain in the brain by heat induced focusing using ultrasound energy under MR planning and thermal imaging control.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
395418
Start Date
September 02, 2022
Effective Date
September 02, 2022
Manufacturer
Country
Israel
Address
5 Nachum Heth St, PO BOX 2059, Tirat Carmel, 39120