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Workstation, diagnostic imaging, x-ray system - ARTG 449647

Access comprehensive regulatory information for Workstation, diagnostic imaging, x-ray system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 449647 and sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Corporation in Japan. The device registration started on May 24, 2024.

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
ARTG 449647
Class IIa
Workstation, diagnostic imaging, x-ray system
ARTG ID: 449647
Good Name: Fujifilm Australia Pty Ltd - Workstation, diagnostic imaging, x-ray system
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Intended Purpose

Console Advance is workstation intended to apply image processing to facilitate diagnosis to digital radiography images from flat panel detectors and/or computed radiography. The Console Advance associate digital images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The Console Advance is intended to be used by healthcare professionals engaged in radiography.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
449647
Start Date
May 24, 2024
Effective Date
May 24, 2024
Manufacturer
Country
Japan
Address
26-30 Nishiazabu 2 Chome, MINATO KU TOKYO, 106 8620