X-ray system, diagnostic, computed tomography, full-body

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

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Available from:
Philips Electronics Australia Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
322947

Public Summary

Summary for ARTG Entry:

322947

Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body

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 Healthcare Suzhou Co Ltd

258 ZhongYuan Road Suzhou Industrial Park

Suzhou, Jiangsu Province, 215024

China

Products

1. X-ray system, diagnostic, computed tomography, full-body

Product Type

Single Device Product

Effective date

10/09/2019

GMDN

37618 X-ray system, diagnostic, computed tomography, full-body

Intended purpose

Diagnostic imaging of patients. The system can be used as a Head and Whole Body Computed

Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multislice

capability simultaneously.

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 04:38:40 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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