Craniotomy Transducer, Type 8862 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
BK Medical Australia Pty Ltd
Class:
Class III
Manufactured by:
B-K Medical ApS Mileparken 34, Herlev, 2730 Denmark
Therapeutic area:
40770 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2014-03-01
