Cone beam computed tomography system, head/neck - ARTG 395110
Access comprehensive regulatory information for Cone beam computed tomography system, head/neck in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 395110 and sponsored by Ajax Dental Supplies Pty Ltd, manufactured by Fussen Technology Co Ltd in China. The device registration started on August 30, 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.
This is a stationary device that is intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It is typically intended for dental diagnostic x-ray images. This is an all-in-one dental X-ray unit that produces diagnostic images for panoramic, cephalometric, and CBCT evaluation.