RSM 1824C / RSM 2430C - Diagnostic x-ray digital imaging conversion system

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

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Available from:
Device Technologies Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
291161

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Public Summary

Summary for ARTG Entry:

291161

Aspenstate Australia Pty Ltd - RSM 1824C / RSM 2430C - Diagnostic x-ray digital imaging conversion

system

ARTG entry for

Medical Device Included Class 1

Sponsor

Aspenstate Australia Pty Ltd

Postal Address

Unit 2 59 Westbrook Street,Kew East, VIC, 3102

Australia

ARTG Start Date

6/07/2017

Product category

Medical Device Class 1

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

DRTECH Corporation

Suite No2 3 Floor 29 Dunchon-daero 541

beon-gil Jungwon-gu Seongnam-si

, Gyeonggi-do,

Korea - Republic of

Products

1. RSM 1824C / RSM 2430C - Diagnostic x-ray digital imaging conversion system

Product Type

Medical device system

Effective date

6/07/2017

GMDN

61109 Diagnostic x-ray digital imaging conversion system

Intended purpose

RoseM, an integrated set of the cassette-size flat-panel digital x-ray detector, system synchronisation unit

and image processing software, is intended to capture the mammography x-ray image and indirectly

convert it into the digital image. The flat-panel digital x-ray detector replaces the radiographic film of

existing analogue x-ray system and the detector and system synchronisation unit do not have any

connection with the x-ray system for the direct operational controls.

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 02.12.2017 at 04:41:48 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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