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Cone beam computed tomography system, head/neck

Australia TGA ARTG Registered Device · Australian Imaging · Xoran Europe Doo · Class IIb · Started September 07, 2022

Good Name: Australian Imaging - Cone beam computed tomography system, head/neck

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
September 07, 2022
Effective Date
September 07, 2022
Sponsor
Manufacturer
Country
Republic of Serbia
Address
Mramorsko brdo bb, Merosina, 18251
Intended purpose

The XCAT is a CT imaging device that constructs a three-dimensional model of the head and neck from images taken during a rotational X-ray sequence. The XCAT is optimized for the imaging of the entire cranio-maxillofacial region.

About this record

Access comprehensive regulatory information for Cone beam computed tomography system, head/neck in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Australian Imaging, manufactured by Xoran Europe Doo in Republic of Serbia. The device registration started on September 07, 2022.

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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