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X-ray system, diagnostic, general-purpose, stationary, digital - ARTG 284568

Access comprehensive regulatory information for X-ray system, diagnostic, general-purpose, stationary, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 284568 and sponsored by Fujifilm Australia Pty Ltd, manufactured by Shimadzu Corporation Medical Systems Division in Japan. The device registration started on January 12, 2017.

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 IIb
ARTG 284568
Class IIb
X-ray system, diagnostic, general-purpose, stationary, digital
ARTG ID: 284568
Good Name: Fujifilm Australia Pty Ltd - X-ray system, diagnostic, general-purpose, stationary, digital
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Intended Purpose

Intended to be used for the digital radiography of patients while they are standing or laying down.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
284568
Start Date
January 12, 2017
Effective Date
January 12, 2017
Manufacturer
Country
Japan
Address
1 Nishinokyo-Kuwabaracho Nakagyo-Ku, Kyoto, 604-8511