Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Ultrasound system, imaging, general-purpose
ARTG entry for
Medical Device Included Class IIa
Paragon Healthcare Pty Ltd
1 / 56 Norcal Road,NUNAWADING, VIC, 3131
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.
Ultrasonix Medical Corp
130-4311 Viking Way
Richmond, BC, V6V 2K9
1. Ultrasound system, imaging, general-purpose
Single Device Product
40761 Ultrasound system, imaging, general-purpose
A general-purpose diagnostic ultrasound imaging system designed for use in a wide variety of body
imaging procedures. This general-purpose system supports a variety of transducers and application
software packages allowing for the collection, display and analysis of diagnostic ultrasound information.
Usages are General-purpose imaging, Anaesthesia, Emergency Medicine, Reproductive Medicine,
Musculo-Skeletal, Point of Care, Cardiac, OB/GYN, endoscopy, breast, prostate, vascular and
Interventional Radiology. Imaging modes include B-Mode, M-Mode, PW and CW Doppler, Colour Doppler,
Power Doppler, Panoramic Imaging and 3D/4D Imaging depending on the software packages and
ultrasound transducers utilised.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:46:37 AEDT
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