Transducer

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217459
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217459

Paragon Healthcare Pty Ltd - Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal

ARTG entry for

Medical Device Included Class IIa

Sponsor

Paragon Healthcare Pty Ltd

Postal Address

1 / 56 Norcal Road,NUNAWADING, VIC, 3131

Australia

ARTG Start Date

19/11/2013

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

B-K Medical ApS

Mileparken 34

Herlev, , 2730

Denmark

Products

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

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

40771 Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal

Intended purpose

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

manually or under endoscopic guidance. It steers, focuses, and detects the ultrasound beam and resulting

echoes electronically. This ultrasound transducer is used with B-mode, M-mode, Doppler, Colour Doppler

(CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This device is

reusable.

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 02:18:20 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