Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Craniotomy Transducer, Type 8862 - 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. Craniotomy Transducer, Type 8862 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
Single Device Product
40770 Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
The device is for use with BK Medical's ultrasound systems. It is a curved array transducer with a sector
angle of 66 degrees. It has a contact surface of 29 x 6mm and can be used with the needle guide that is
used for interventional procedures for biopsying of the brain following craniotomy.
Craniotomy Transducer Type 8862 is designed for intraoperative neurosurgical imaging, as well as spinal
cord, intraoperative, and pediatric imaging.
Nil variant (as 1 device) No variants
No Specific Conditions included on Record
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