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Diagnostic digital imaging system workstation application software - ARTG 397191

Access comprehensive regulatory information for Diagnostic digital imaging system workstation application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 397191 and sponsored by Shimadzu Medical Systems Oceania Pty Ltd, manufactured by Konica Minolta Inc in Japan. The device registration started on October 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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Class IIa
ARTG 397191
Class IIa
Diagnostic digital imaging system workstation application software
ARTG ID: 397191
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - Diagnostic digital imaging system workstation application software
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Intended Purpose

This application software receives X-ray images from modality console, and perform image processing, and output the images for medical diagnostic

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
397191
Start Date
October 07, 2022
Effective Date
October 07, 2022
Manufacturer
Country
Japan
Address
1 Sakura-machi Hino-shi, TOKYO, 1918511