Hand-held intraoral dental x-ray system, digital

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Vatech Medical Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
290298

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Public Summary

Summary for ARTG Entry:

290298

Vatech Medical Pty Ltd - Hand-held intraoral dental x-ray system, digital

ARTG entry for

Medical Device Included Class IIb

Sponsor

Vatech Medical Pty Ltd

Postal Address

Suite 5.04 Gateway Business Park, 63-79 Parramatta Road,Silverwater, NSW, 2128

Australia

ARTG Start Date

16/06/2017

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Vatech Co Ltd

13 Samsung 1-ro 2-gil

Hwaseong-si, Gyeonggi-do, 18449

Korea - Republic of

Products

1. Hand-held intraoral dental x-ray system, digital

Product Type

Single Device Product

Effective date

16/06/2017

GMDN

44606 Hand-held intraoral dental x-ray system, digital

Intended purpose

A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption

pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the

diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity

structures. It is designed to be easily carried from location to location by a single operator. The sensor is

placed in the mouth, the purpose being to visualize a limited region in detail.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:44:10 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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