Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Burr Hole Transducer, Type 8863 - Transducer assembly, ultrasound,
diagnostic, intracorporeal, surgical
ARTG entry for
Medical Device Included Class III
Paragon Healthcare Pty Ltd
1 / 56 Norcal Road,NUNAWADING, VIC, 3131
ARTG Start Date
Medical Device Class III
- 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.
B-K Medical ApS
Herlev, , 2730
1. Burr Hole Transducer, Type 8863 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
Single Device Product
40770 Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
The device is designed for use with BK Medical's ultrasound systems. It is a curved array transducer with
a sector angle of up to 46 degrees. It has a contact surface of 10.0 x 8.6mm. It can be used with a needle
guide that provides guidance of a needle for biopsy and drainage in the brain.
Burr Hole Transducer Type 8863 is designed for intraoperative neurosurgical ultrasound imaging of the
brain through a burr hole. It can also be used for spinal cord and intraoperative ultrasound imaging.
Nil variant (as 1 device) No variants
No Specific Conditions included on Record
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