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Radiological breast positioning device, wearable - ARTG 433091

Access comprehensive regulatory information for Radiological breast positioning device, wearable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 433091 and sponsored by Gamma Gurus Pty Ltd, manufactured by Chabner XRT LLC in United States of America. The device registration started on January 09, 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.

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Class I
ARTG 433091
Class I
Radiological breast positioning device, wearable
ARTG ID: 433091
Good Name: Gamma Gurus Pty Ltd - Radiological breast positioning device, wearable
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Intended Purpose

The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Not intended for use with patients under 12 years of age.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
433091
Start Date
January 09, 2024
Effective Date
January 09, 2024
Manufacturer
Country
United States of America
Address
200 Summerfield Street, Scarsdale, NY, 10583