Stationary

Main information

  • Trade name:
  • Stationary intraoral dental x-ray system, digital
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Stationary intraoral dental x-ray system, digital
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221577
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221577

William Green Pty Ltd - Stationary intraoral dental x-ray system, digital

ARTG entry for

Medical Device Included Class IIb

Sponsor

William Green Pty Ltd

Postal Address

47 - 49 Mary Parade,RYDALMERE, NSW, 2116

Australia

ARTG Start Date

24/03/2014

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

23-4 Seogu-dong Hwaseong-si

Gyeonggi-do, , 445-170

Korea - Republic of

Products

1. Stationary intraoral dental x-ray system, digital

Product Type

Single Device Product

Effective date

24/03/2014

GMDN

42297 Stationary intraoral dental x-ray system, digital

Intended purpose

This is a diagnostic dental x-ray system designed for permanent fixture in one location 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. The Xray system is outside the

mouth and the sensor to record the image is placed inside the mouth.

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 05:27:36 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