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

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

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Public Summary

Summary for ARTG Entry:


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


ARTG entry for

Medical Device Included Class 1


Aspenstate Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class 1



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.




DRTECH Corporation

Suite No2 3 Floor 29 Dunchon-daero 541

beon-gil Jungwon-gu Seongnam-si

, Gyeonggi-do,

Korea - Republic of


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

Product Type

Medical device system

Effective date



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

Public Summary

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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.

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