Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Transducer assembly, ultrasound, diagnostic, extracorporeal, hand-held
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, extracorporeal, hand-held
Single Device Product
40768 Extracorporeal ultrasound imaging system transducer, hand-held
An extracorporeal diagnostic ultrasound transducer assembly that is moved by hand from location to
location on the intact surface of a patient's body during imaging applications. Depending on configuration,
it is used for General-purpose imaging, Anaesthesia, Emergency Medicine, Reproductive Medicine,
Musculo-Skeletal, Point of Care, Cardiac, OB/GYN, endoscopy, breast, prostate, vascular, Intra-operative
and Interventional Radiology procedures. 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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