Ultrasound

Main information

  • Trade name:
  • Ultrasound system, imaging, application program software
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ultrasound system, imaging, application program software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221897
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221897

The Trustee for Trackside Technologies - Ultrasound system, imaging, application program software

ARTG entry for

Medical Device Included Class 1

Sponsor

The Trustee for Trackside Technologies

Postal Address

22 Campbell Street,KEW, VIC, 3101

Australia

ARTG Start Date

2/04/2014

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

UTC Imaging BV

Kruisstraat 65

, GD Stein, 6171

Netherlands

Products

1. Ultrasound system, imaging, application program software

Product Type

Single Device Product

Effective date

2/04/2014

GMDN

40873 Ultrasound system, imaging, application program software

Intended purpose

Ultrasound imaging system application software - GMDN code is 40873

An individual software program or group of programs, routines or algorithms that add specific image

processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of

applications programs and routines are included with such computer-controlled imaging systems and they

can be upgraded to correct programming errors or to add new system capabilities. Some applications

software programs or program packages must be combined with specific hardware or firmware

configurations in order to function as intended. Applications program packages are typically identified by a

proprietary name and "version" or "upgrade" number.

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 09.11.2017 at 11:21:48 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