ESAOTE

Main information

  • Trade name:
  • ESAOTE MyLabSeven, MyLabAlpha,MyLabTwice - Ultrasound system, imaging, general-purpose
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ESAOTE MyLabSeven, MyLabAlpha,MyLabTwice - Ultrasound system, imaging, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222114
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222114

Whiteley Diagnostic Pty Ltd - ESAOTE MyLabSeven, MyLabAlpha,MyLabTwice - Ultrasound system,

imaging, general-purpose

ARTG entry for

Medical Device Included Class IIa

Sponsor

Whiteley Diagnostic Pty Ltd

Postal Address

PO Box 5137,ELANORA HEIGHTS, NSW, 2101

Australia

ARTG Start Date

8/04/2014

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

Esaote SPA

Via Siffredi 58

, Genova, 16153

Italy

Products

1. ESAOTE MyLabSeven, MyLabAlpha,MyLabTwice - Ultrasound system, imaging, general-purpose

Product Type

Medical device system

Effective date

8/04/2014

GMDN

40761 Ultrasound system, imaging, general-purpose

Intended purpose

A general-purpose diagnostic ultrasound imaging system designed exclusively for use in a wide variety of

both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging procedures. A

general-purpose system supports a wide variety of transducers and related application software packages

allowing for the collection, display and analysis of ultrasound information. Usages are, e.g.

general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler

or colour Doppler, depending on the operating system specific software packages and compatible

ultrasound transducers.

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 09.11.2017 at 10:46:38 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