Stationary

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218562
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218562

Henry Schein Halas - Stationary cephalometric x-ray system, digital

ARTG entry for

Medical Device Included Class IIb

Sponsor

Henry Schein Halas

Postal Address

Locked Bag 5003,ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

14/12/2013

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

PaloDEx Group Oy

Nahkelantie 160

Tuusula, , FI 04300

Finland

Products

1. Stationary cephalometric x-ray system, digital

Product Type

Single Device Product

Effective date

14/12/2013

GMDN

43620 Stationary cephalometric x-ray system, digital

Intended purpose

This range (Orrtoceph/Orthopantomographs) of x-ray apparatus helps produce x-ray radioographs of

dentition, TMJ and other oral structures, and its cephalometric option is used for cephalometric

examination and cephalometric radiography. OPG helps produce conventional images as well as x-ray

projection images of an examined volume for reconstruction of an extra dimensional view.

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 05:29:58 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