Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Fujifilm Australia Pty Ltd · Shimadzu Corporation Medical Systems Division · Class IIb · Started January 12, 2017

Good Name: Fujifilm Australia Pty Ltd - X-ray system, diagnostic, general-purpose, stationary, digital

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: January 12, 2017
Effective Date: January 12, 2017

Sponsor

Name: Fujifilm Australia Pty Ltd

Manufacturer

Name: Shimadzu Corporation Medical Systems Division
Country: Japan
Address: 1 Nishinokyo-Kuwabaracho Nakagyo-Ku, Kyoto, 604-8511

Intended purpose

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

About this record

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 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.