Hand-held intraoral dental x-ray system, digital
Access comprehensive regulatory information for Hand-held intraoral dental x-ray system, 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 October 25, 2022.
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.
The device is intended to use by trained dentists and dental technicians as a mobile, extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. It is used for both adult and children.