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SPECT system, annular detector array - ARTG 313206

Access comprehensive regulatory information for SPECT system, annular detector array in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 313206 and sponsored by Gamma Gurus Pty Ltd, manufactured by Spectrum Dynamics Medical Ltd in Israel. The device registration started on January 11, 2019.

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 IIa
ARTG 313206
Class IIa
SPECT system, annular detector array
ARTG ID: 313206
Good Name: Gamma Gurus Pty Ltd - SPECT system, annular detector array
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Intended Purpose

The gamma camera is intended to detect the location and distribution of gamma emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The scanner supports imaging modes such as SPECT, Multi-gated SPECT and multi-isotope SPECT imaging.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
313206
Start Date
January 11, 2019
Effective Date
January 11, 2019
Manufacturer
Country
Israel
Address
22 Bareket Street North Industrial Park PO Box 3033, Caesarea, 3079837