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X-ray generator, diagnostic, mobile - ARTG 282759

Access comprehensive regulatory information for X-ray generator, diagnostic, mobile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 282759 and sponsored by Optima Healthcare Group, manufactured by Dexcowin Co Ltd in South Korea. The device registration started on November 22, 2016.

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 282759
Class IIb
X-ray generator, diagnostic, mobile
ARTG ID: 282759
Good Name: Optima Healthcare Group - X-ray generator, diagnostic, mobile
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DJ Fang

DJ Fang

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Intended Purpose

An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a mobile x-ray system, e.g. a system designed to be pushed or driven to various locations within a facility. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). It includes transformer, inverter, and capacitor discharge generator designs. It typically comprises a control assembly (console) and high voltage transformer assembly or is of a mono-tank generator design. This generator is an integral component of a mobile diagnostic x-ray system.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
282759
Start Date
November 22, 2016
Effective Date
November 22, 2016
Manufacturer
Country
South Korea
Address
#905 2 Gasan Digital 1-ro, Geumcheon-gu, Seoul