Radiology picture archiving and communication system application software

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

Buy It Now

Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIa
Authorization status:
Included
Authorization number:
339797

Public Summary

Summary for ARTG Entry:

339797

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

application software

ARTG entry for

Medical Device Included Class IIa

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

20/07/2020

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

Hyland Software Canada ULC

111 Peter Street Suite 540

Toronto, Ontario, M5V 2H1

Canada

Products

1 . Radiology picture archiving and communication system application software

Product Type

Single Device Product

Effective Date

20/07/2020

GMDN

41670 Radiology picture archiving and communication system application software

Intended Purpose

The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and

other patient-related information for conducting diagnostic review, planning, and reporting through the interactive display and

manipulation of medical data, including mammography. NilRead also allows users to collaborate by sharing application sessions.

Mammographic images should only be viewed with a monitor approved by the FDA for viewing mammographic images, or monitors

with similar specifications. On portable (mobile) platforms, this device is not intended to replace full workstations and should be

used only when there is no access to a workstation. It is the user's responsibility to ensure the software is installed on appropriate

hardware and to verify display image quality is suitable for the clinical application. Mobile use is not intended for diagnostic review

of Mammography and DBT.

NilRead is intended for use by physicians trained in reviewing and interpreting medical images.

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 22.07.2020 at 08:29:48 AEST

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

Search alerts related to this product

Share this information