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SPECT/CT diagnostic imaging system

Access comprehensive regulatory information for SPECT/CT diagnostic imaging system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Gamma Gurus Pty Ltd, manufactured by Spectrum Dynamics Medical Ltd in Israel. The device registration started on December 21, 2018.

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
SPECT/CT diagnostic imaging system
Australia TGA ARTG Registered Device
Good Name: Gamma Gurus Pty Ltd - SPECT/CT diagnostic imaging system
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Intended Purpose

A radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 21, 2018
Effective Date
December 21, 2018
Manufacturer
Country
Israel
Address
22 Bareket Street North Industrial Park PO Box 3033, Caesarea, 3079837