Australia TGA ARTG record

X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital

Australia TGA ARTG Registered Device · Shimadzu Medical Systems Oceania Pty Ltd · Genoray Co Ltd · Class IIb · Started September 27, 2021

Good Name: Shimadzu Medical Systems Oceania Pty Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: September 27, 2021
Effective Date: September 27, 2021

Sponsor

Name: Shimadzu Medical Systems Oceania Pty Ltd

Manufacturer

Name: Genoray Co Ltd
Country: South Korea
Address: 60 Dunchondaero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13212

Intended purpose

The device is a mobile C-Arm X-ray system, is intended to provide fluoroscopic and radiographic X-ray images of the patient during diagnosis urologic, orthopedic, neurologic, anesthesiology and others

About this record

Access comprehensive regulatory information for X-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Shimadzu Medical Systems Oceania Pty Ltd, manufactured by Genoray Co Ltd in South Korea. The device registration started on September 27, 2021.

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.