Australia TGA ARTG record

X-ray system, diagnostic, computed tomography, limited view field

Australia TGA ARTG Registered Device · Australian Imaging · Xoran Europe Doo · Class IIb · Started July 08, 2022

Good Name: Australian Imaging - X-ray system, diagnostic, computed tomography, limited view field

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 08, 2022
Effective Date: July 08, 2022

Sponsor

Name: Australian Imaging

Manufacturer

Name: Xoran Europe Doo
Country: Republic of Serbia
Address: Mramorsko brdo bb, Merosina, 18251

Intended purpose

The MiniCAT 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 MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, and sinuses

About this record

Access comprehensive regulatory information for X-ray system, diagnostic, computed tomography, limited view field 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 July 08, 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.