Ultrasound system, imaging, general-purpose

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Medical Devices and Testing Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
289442

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Public Summary

Summary for ARTG Entry:

289442

Medical Devices and Testing Pty Ltd - Ultrasound system, imaging, general-purpose

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medical Devices and Testing Pty Ltd

Postal Address

PO Box 114,Pyrmont, NSW, 2009

Australia

ARTG Start Date

29/05/2017

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

Alpinion Medical Systems Co Ltd

1FL and 6FL Verdi Tower 72 Digital-ro (St)

26-gil (Rd)

Guro-gu, Seoul, 08393

Korea - Republic of

Products

1. Ultrasound system, imaging, general-purpose

Product Type

Single Device Product

Effective date

29/05/2017

GMDN

40761 Ultrasound system, imaging, general-purpose

Intended purpose

for use in a wide variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic)

body imaging procedures. It 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,

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 03.11.2017 at 06:53:17 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

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