Radiology picture archiving and communication system application software

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

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class Im
Authorization status:
Included
Authorization number:
322389

Public Summary

Summary for ARTG Entry:

322389

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Radiology picture archiving and communication system

application software

ARTG entry for

Medical Device Included Class Im

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

28/08/2019

Product category

Medical Device Class Im

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

Change Healthcare Canada Company

10711 Cambie Road

Richmond, BC, V6X 3G5

Canada

Products

1. Radiology picture archiving and communication system application software

Product Type

Single Device Product

Effective date

28/08/2019

GMDN

41670 Radiology picture archiving and communication system application software

Intended purpose

Change Healthcare Enterprise Viewer is a medical image viewer that enables users to access imaging

studies and patient documentation stored in multiple data sources such as picture archiving and

communication system (PACS) or a vendor neutral archive.

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 05:53:54 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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