ARTG 398331Stationary panoramic/tomographic dental x-ray system, digital
ARTG ID: 398331 · Shimadzu Medical Systems Oceania Pty Ltd · Genoray Co Ltd · Class IIb · Started October 25, 2022
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - Stationary panoramic/tomographic dental x-ray system, digital
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 398331
- Start Date
- October 25, 2022
- Effective Date
- October 25, 2022
- Name
- Genoray Co Ltd
- Country
- South Korea
- Address
- 60 Dunchondaero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13212
The X-ray unit system is a diagnostic imaging system which consists of multiple image acquisition modes; panoramic, cephalometric, and CBCT (Cone Beam Computed Tomography). The X-ray unit system is used for dental radiographic examination and diagnosis of teeth, jaw, oral structures and skull. The device is to be operated and used by dentists and other legally qualified professionals.
Access comprehensive regulatory information for Stationary panoramic/tomographic dental x-ray system, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 398331 and 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.