Craniotomy

Main information

  • Trade name:
  • Craniotomy Transducer, Type 8862 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Craniotomy Transducer, Type 8862 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220629
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220629

Paragon Healthcare Pty Ltd - Craniotomy Transducer, Type 8862 - Transducer assembly, ultrasound,

diagnostic, intracorporeal, surgical

ARTG entry for

Medical Device Included Class III

Sponsor

Paragon Healthcare Pty Ltd

Postal Address

1 / 56 Norcal Road,NUNAWADING, VIC, 3131

Australia

ARTG Start Date

1/03/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

B-K Medical ApS

Mileparken 34

Herlev, , 2730

Denmark

Products

1. Craniotomy Transducer, Type 8862 - Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical

Product Type

Single Device Product

Effective date

1/03/2014

GMDN

40770 Transducer assembly, ultrasound, diagnostic, intracorporeal, surgical

Functional description

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.

Intended purpose

Craniotomy Transducer Type 8862 is designed for intraoperative neurosurgical imaging, as well as spinal

cord, intraoperative, and pediatric imaging.

Variant information

Nil variant (as 1 device) No variants

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 03:32:36 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information