Australia TGA ARTG record

X-ray generator, diagnostic, mobile

Australia TGA ARTG Registered Device · Optima Healthcare Group · Dexcowin Co Ltd · Class IIb · Started November 22, 2016

Good Name: Optima Healthcare Group - X-ray generator, diagnostic, mobile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 22, 2016
Effective Date: November 22, 2016

Sponsor

Name: Optima Healthcare Group

Manufacturer

Name: Dexcowin Co Ltd
Country: South Korea
Address: #905 2 Gasan Digital 1-ro, Geumcheon-gu, Seoul

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.

About this record

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 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.