Summary for ARTG Entry:
GE Healthcare Australia Pty Ltd - Ultrasound system, imaging, cardiovascular
ARTG entry for
Medical Device Included Class IIa
GE Healthcare Australia Pty Ltd
PO Box 5079,PARRAMATTA DC, NSW, 2150
ARTG Start Date
Medical Device Class IIa
- 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 Medical Systems Israel Ltd
4 Etgar Street Tirat Carmel
, , 39120
1. Ultrasound system, imaging, cardiovascular
Single Device Product
40763 Ultrasound system, imaging, cardiovascular
This ultrasound imaging system is intended for use in extracorporeal imaging procedures involving the
heart and blood vessels. Included are software packages that support a variety of static or real time
cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood
flow characteristics and functional/anatomical problems associated wtih myocardial infarction.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:13:03 AEDT
This is not an ARTG Certificate document.
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