Radiography digital imaging system remote control

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

Buy It Now

Available from:
Philips Electronics Australia Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
322945

Public Summary

Summary for ARTG Entry:

322945

Philips Electronics Australia Ltd - Radiography digital imaging system remote control

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Philips Electronics Australia Ltd

Postal Address

Locked Bag 30,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

10/09/2019

Product category

Medical Device Class 1

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

Philips Medical Systems DMC GmbH

Rontgenstrasse 24

, Hamburg, 22335

Germany

Products

1. Radiography digital imaging system remote control

Product Type

Single Device Product

Effective date

10/09/2019

GMDN

61587 Radiography digital imaging system remote control

Intended purpose

A multi-functional general R/F system, suitable for all routine radiography and fluoroscopy exams,

including specialist areas like angiography or pediatric work, excluding mammography.

Specific Conditions

© 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 02.11.2019 at 04:39:20 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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