Summary for ARTG Entry:
GE Healthcare Australia Pty Ltd - X-ray system, diagnostic, mammographic, stationary, digital
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.
GE Ultrasound Korea Ltd
9 Sunhwan-ro 214beon-gii Jungwon-gu
Korea - Republic of
1. X-ray system, diagnostic, mammographic, stationary, digital
Single Device Product
37672 X-ray system, diagnostic, mammographic, stationary, digital
This digitial mammography x-ray system is intended to compress and image the breas and to record the
absorption pattern of x-ray beams passed through the breast onto various image archive media, e.g. film,
paper and digital/video formats. It uses digital techniques for image capture, display and manipulation.It is
intended to be used for breast cancer screening and for the placement of biopsy markers,
stereotactic biopsy and lesion localization.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 05:28:07 AEDT
This is not an ARTG Certificate document.
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