Main information

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



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

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221434
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


GE Healthcare Australia Pty Ltd - Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held

ARTG entry for

Medical Device Included Class IIa


GE Healthcare Australia Pty Ltd

Postal Address

PO Box 5079,PARRAMATTA DC, NSW, 2150


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Humanscan Co Ltd

Room 301 303 319 320 Sihwa APT Factory

Jiwon-ro 107 Danwon-gu

Ansan-si, Gyeonggi-do, 425-836

Korea - Republic of


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

Product Type

Single Device Product

Effective date



40768 Extracorporeal ultrasound imaging system transducer, hand-held

Intended purpose

This ultrasound transducer assembly is intended to be extracorporeal and includes single or multiple

element transducer assembly configurations that convert electric voltages into an ultrasound beam. It is

intended to be a held-hand device that moves from location to location on the intact surface of a patient's

body during ultrasound imaging applications.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:05:31 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.

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