Ultrasonic electromagnetic-guided

Main information

  • Trade name:
  • Ultrasonic/electromagnetic-guided needle kit
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ultrasonic/electromagnetic-guided needle kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218385
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218385

Fujifilm Sonosite Australasia Pty Ltd - Ultrasonic/electromagnetic-guided needle kit

ARTG entry for

Medical Device Included Class IIa

Sponsor

Fujifilm Sonosite Australasia Pty Ltd

Postal Address

PO Box 57,BELROSE WEST, NSW, 2085

Australia

ARTG Start Date

11/12/2013

Product category

Medical Device Class IIa

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

Soma Access Systems LLC

109 Laurens Road

Suite 4C

Greenville, South Carolina, 29607

United States Of America

Products

1. Ultrasonic/electromagnetic-guided needle kit

Product Type

Single Device Product

Effective date

11/12/2013

GMDN

60443 Ultrasonic/electromagnetic-guided needle kit

Intended purpose

The AxoTrack I Sterile Procedure Kit is intended to provide physicians with tools for electromagnetic

tracking instruments with respect to image data.

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 10:39:08 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

25-4-2018

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry

Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry

FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. Posted 04/25/2018

FDA - U.S. Food and Drug Administration

There are no news related to this product.