Ultrasound

Main information

  • Trade name:
  • Ultrasound system, imaging, general-purpose
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ultrasound system, imaging, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221188
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221188

Paragon Healthcare Pty Ltd - Ultrasound system, imaging, general-purpose

ARTG entry for

Medical Device Included Class IIa

Sponsor

Paragon Healthcare Pty Ltd

Postal Address

1 / 56 Norcal Road,NUNAWADING, VIC, 3131

Australia

ARTG Start Date

12/03/2014

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

Ultrasonix Medical Corp

130-4311 Viking Way

Richmond, BC, V6V 2K9

Canada

Products

1. Ultrasound system, imaging, general-purpose

Product Type

Single Device Product

Effective date

12/03/2014

GMDN

40761 Ultrasound system, imaging, general-purpose

Intended purpose

A general-purpose diagnostic ultrasound imaging system designed for use in a wide variety of body

imaging procedures. This general-purpose system supports a variety of transducers and application

software packages allowing for the collection, display and analysis of diagnostic ultrasound information.

Usages are General-purpose imaging, Anaesthesia, Emergency Medicine, Reproductive Medicine,

Musculo-Skeletal, Point of Care, Cardiac, OB/GYN, endoscopy, breast, prostate, vascular and

Interventional Radiology. Imaging modes include B-Mode, M-Mode, PW and CW Doppler, Colour Doppler,

Power Doppler, Panoramic Imaging and 3D/4D Imaging depending on the software packages and

ultrasound transducers utilised.

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 10.11.2017 at 01:46:37 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