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:
  • 221189
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


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

ARTG entry for

Medical Device Included Class IIa


Paragon Healthcare Pty Ltd

Postal Address

1 / 56 Norcal Road,NUNAWADING, VIC, 3131


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.




Ultrasonix Medical Corp

130-4311 Viking Way

Richmond, BC, V6V 2K9



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

An extracorporeal diagnostic ultrasound transducer assembly that is moved by hand from location to

location on the intact surface of a patient's body during imaging applications. Depending on configuration,

it is used for General-purpose imaging, Anaesthesia, Emergency Medicine, Reproductive Medicine,

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

and Interventional Radiology procedures. The transducer is used with B-mode, M-mode, Doppler, Colour

Doppler, Power Doppler and duplex/triplex (combination imaging, Doppler and/or Colour Doppler)

scanning capabilities, depending on the software and hardware capability of the Ultrasound console to

which the transducer is attached.

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 01:46:21 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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