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Nuclear medicine system, gamma camera, application program software - ARTG 483485

Access comprehensive regulatory information for Nuclear medicine system, gamma camera, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 483485 and sponsored by Clifford Hallam Healthcare Pty Ltd, manufactured by Mediso Medical Imaging Systems Ltd in Hungary. The device registration started on March 21, 2025.

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
ARTG 483485
Class IIb
Nuclear medicine system, gamma camera, application program software
ARTG ID: 483485
Good Name: Clifford Hallam Healthcare Pty Ltd - Nuclear medicine system, gamma camera, application program software
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Intended Purpose

A Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. This device is not indicated for mammography use or dental diagnostics.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483485
Start Date
March 21, 2025
Effective Date
March 21, 2025
Manufacturer
Country
Hungary
Address
Laborc utca 3, Budapest, 1037