Transducer

Main information

  • Trade name:
  • Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219409
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219409

Mindray Medical Australia Pty Ltd - Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held

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. Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held

Product Type

Single Device Product

Effective date

21/01/2014

GMDN

40768 Extracorporeal ultrasound imaging system transducer, hand-held

Intended purpose

An ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's

body during general-purpose imaging applications. It includes single or multiple element transducer

configurations that convert electric voltages into an ultrasound beam. Typically used with coupling gels to

ensure adequate contact with the patient it steers, focuses and detects the ultrasound beam and resulting

echoes mechanically or electronically. This ultrasound imaging transducer is used with A-mode, B-mode,

M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow)

scanning capabilities. This is a reusable device.

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 07:40:12 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