ARTG 398175Dental digital imaging sensor, intraoral
ARTG ID: 398175 · Shimadzu Medical Systems Oceania Pty Ltd · Genoray Co Ltd · Class IIa · Started October 21, 2022
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - Dental digital imaging sensor, intraoral
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 398175
- Start Date
- October 21, 2022
- Effective Date
- October 21, 2022
- Name
- Genoray Co Ltd
- Country
- South Korea
- Address
- 60 Dunchondaero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13212
The device is intended for use as intraoral imaging system which obtains dental images. GIX-1 consists of Image acquisition part as an Intraoral Sensor and Image processing Software. It provides excellent quality images to users for diagnosis through processing row images acquired from intraoral sensor.
Access comprehensive regulatory information for Dental digital imaging sensor, intraoral in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 398175 and sponsored by Shimadzu Medical Systems Oceania Pty Ltd, manufactured by Genoray Co Ltd in South Korea. The device registration started on October 21, 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.