Medical image management system

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

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Available from:
Stryker Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322623

Public Summary

Summary for ARTG Entry:

322623

Stryker Australia Pty Ltd - Medical image management system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

3/09/2019

Product category

Medical Device Class IIa

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

Stryker Leibinger GmbH & Co KG

Botzinger Strasse 41

Freiburg, , 79111

Germany

Products

1. Medical image management system

Product Type

Single Device Product

Effective date

3/09/2019

GMDN

60723 Medical image management system

Intended purpose

A computer controlled image guided surgery system intended to provide static location information derived

from image processing of X-ray images.

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 05:18:45 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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