Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
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. Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
Single Device Product
40771 Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
An electronic multi-element array ultrasound transducer designed for intra-vaginal imaging. Biopsy is
possible via an optional needle guide attachment. This device is reusable. The transducer is used with
B-mode, M-mode, Doppler, Colour Doppler, Power Doppler and duplex/triplex (combination imaging,
Doppler and/or Colour Doppler) scanning capabilities, depending on the software and hardware capability
of the Ultrasound console to which the transducer is attached.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:46:05 AEDT
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