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D-Spect- Annular Detector Array - SPECT system, annular detector array

Access comprehensive regulatory information for D-Spect- Annular Detector Array - SPECT system, annular detector array in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Gamma Gurus Pty Ltd, manufactured by Spectrum Dynamics Medical Ltd in Israel. The device registration started on June 13, 2023.

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
Class IIa
D-Spect- Annular Detector Array - SPECT system, annular detector array
Australia TGA ARTG Registered Device
Good Name: Gamma Gurus Pty Ltd - D-Spect- Annular Detector Array - 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
Start Date
June 13, 2023
Effective Date
June 13, 2023
Manufacturer
Country
Israel
Address
22 Bareket Street North Industrial Park PO Box 3033, Caesarea, 3079837