Main information

  • Trade name:
  • Transducer assembly, ultrasound, diagnostic, intracorporeal, rectal
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Transducer assembly, ultrasound, diagnostic, intracorporeal, rectal
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219412
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Mindray Medical Australia Pty Ltd - Transducer assembly, ultrasound, diagnostic, intracorporeal, rectal

ARTG entry for

Medical Device Included Class IIa


Mindray Medical Australia Pty Ltd

Postal Address

19 Harker Street,BURWOOD, VIC, 3125


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.




Shenzhen Mindray Bio Medical Electronics Co

Mindray Building Keji 12th Road South Hi-Tech

Industrial Park

Nanshan, Shenzhen, 518057



1. Transducer assembly, ultrasound, diagnostic, intracorporeal, rectal

Product Type

Single Device Product

Effective date



40772 Transducer assembly, ultrasound, diagnostic, intracorporeal, rectal

Intended purpose

An ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either

manually or under endoscopic guidance. Included is a variety of single or multiple element transducer

assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and

detects the ultrasound beam and resulting echoes either mechanically or electronically. Also known as a

rectal, transrectal, or prostate probe, it may incorporate a biopsy needle guidance channel as part of the

transducer casing or housing assembly design. 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

Public Summary

Page 1 of

Produced at 10.11.2017 at 07:39:24 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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