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Stationary panoramic dental x-ray system, digital - ARTG 398330

Access comprehensive regulatory information for Stationary panoramic 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 398330 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.

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Class IIb
ARTG 398330
Class IIb
Stationary panoramic dental x-ray system, digital
ARTG ID: 398330
Good Name: Shimadzu Medical Systems Oceania Pty Ltd - Stationary panoramic dental x-ray system, digital
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Intended Purpose

The digital X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
398330
Start Date
October 25, 2022
Effective Date
October 25, 2022
Manufacturer
Country
South Korea
Address
60 Dunchondaero 541 beon-gil Jungwon-gu, Seongnam-si, Gyeonggi-do, 13212