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Computed radiography cassette/storage phosphor screen, mammographic

Access comprehensive regulatory information for Computed radiography cassette/storage phosphor screen, mammographic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Shimadzu Medical Systems Oceania Pty Ltd, manufactured by Konica Minolta Inc in Japan. The device registration started on August 27, 2018.

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
Computed radiography cassette/storage phosphor screen, mammographic
Australia TGA ARTG Registered Device
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - Computed radiography cassette/storage phosphor screen, mammographic
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Intended Purpose

Intended for use in the acquisition and process of mammographic images of human anatomy. It is intended to replace radiographic film/screen system in mammograpy-purpose diagnostic procedures, and is used in a computed radiography system.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 27, 2018
Effective Date
August 27, 2018
Manufacturer
Country
Japan
Address
1 Sakura-machi Hino-shi, TOKYO, 1918511