ARTG 473965R2 STUDIO Q - Stationary panoramic/tomographic dental x-ray system, digital
ARTG ID: 473965 · Dr K Y Lee Pty Ltd · MegaGen Implant Co Ltd · Class IIb · Started December 19, 2024
Good Name: Dr K Y Lee Pty Ltd - R2 STUDIO Q - Stationary panoramic/tomographic dental x-ray system, digital
- Risk Class
- Class IIb
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 473965
- Start Date
- December 19, 2024
- Effective Date
- December 19, 2024
- Country
- South Korea
- Address
- 45 Secheon-ro 7-gil Dasa-eup, Dalseong-gun, Daegu, 42921
R2 STUDIO Q is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals.
Access comprehensive regulatory information for R2 STUDIO Q - 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 473965 and sponsored by Dr K Y Lee Pty Ltd, manufactured by MegaGen Implant Co Ltd in South Korea. The device registration started on December 19, 2024.
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.