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:
  • 219408
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219408

Mindray Medical Australia Pty Ltd - Ultrasound system, imaging, general-purpose

ARTG entry for

Medical Device Included Class IIa

Sponsor

Mindray Medical Australia Pty Ltd

Postal Address

19 Harker Street,BURWOOD, VIC, 3125

Australia

ARTG Start Date

21/01/2014

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

Shenzhen Mindray Bio Medical Electronics Co

Mindray Building Keji 12th Road South Hi-Tech

Industrial Park

Nanshan, Shenzhen, 518057

China

Products

1. Ultrasound system, imaging, general-purpose

Product Type

Single Device Product

Effective date

21/01/2014

GMDN

40761 Ultrasound system, imaging, general-purpose

Intended purpose

A range of general-purpose diagnostic ultrasound imaging systems designed exclusively for use in a wide

variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging

procedures. These general-purpose systems supports a wide variety of transducers and related

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

Usages are, e.g. general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular,

intra-surgical, Doppler or colour Doppler, depending on the operating system specific software packages

and compatible ultrasound transducers.

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 07:40:28 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