Australia - English - Department of Health (Therapeutic Goods Administration)
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
Unit 2 59 Westbrook Street,Kew East, VIC, 3102
ARTG Start Date
Medical Device Class 1
- 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.
Suite No2 3 Floor 29 Dunchon-daero 541
beon-gil Jungwon-gu Seongnam-si
Korea - Republic of
1. RSM 1824C / RSM 2430C - Diagnostic x-ray digital imaging conversion system
Medical device system
61109 Diagnostic x-ray digital imaging conversion system
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.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:41:48 AEDT
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