Pure Global

X-ray system, diagnostic, general-purpose, application program software

Access comprehensive regulatory information for X-ray system, diagnostic, general-purpose, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Canon Australia Pty Ltd, manufactured by Canon Inc in Japan. The device registration started on November 20, 2020.

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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TGA ARTG Official Data
Class IIa
Class IIa
X-ray system, diagnostic, general-purpose, application program software
Australia TGA ARTG Registered Device
Good Name: Canon Australia Pty Ltd - X-ray system, diagnostic, general-purpose, application program software
Pure Global
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Intended Purpose

This device provides digital X-Ray image for diagnosis of disease, injury or any applicable health problem. The image is obtained as the result of imaging X-Ray passed through human body with the X-Ray flat panel detector and importing digital signals output from the detector into the image processor.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 20, 2020
Effective Date
November 20, 2020
Manufacturer
Country
Japan
Address
9-1 Imaikami-cho Nakahara-Ku, Kawasaki, Kanagawa, 211-8501