Summary for ARTG Entry:
GE Healthcare Australia Pty Ltd - X-ray system, diagnostic, general-purpose, application program software
ARTG entry for
Medical Device Included Class IIb
GE Healthcare Australia Pty Ltd
PO Box 5079,PARRAMATTA DC, NSW, 2150
ARTG Start Date
Medical Device Class IIb
- 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.
Konica Minolta Inc
1 Sakura-machi Hino-shi
TOKYO, , 1918511
1. X-ray system, diagnostic, general-purpose, application program software
Single Device Product
40866 X-ray system, diagnostic, general-purpose, application program software
This device is a software program for installation on a PC. It is intended to perform image processing of
X-ray images received from a diagnostic, general-purpose, portable, digital x-ray system. This software
device adds patient data received from RIS etc. and sends diagnosis images to PACS etc. Furthermore ,
this software can send requests for exposure conditions to the X-ray device and receive irradiation results.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:28:23 AEDT
This is not an ARTG Certificate document.
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