Coil

Main information

  • Trade name:
  • Coil, MRI, radio frequency
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Coil, MRI, radio frequency
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221221
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221221

GE Healthcare Australia Pty Ltd - Coil, MRI, radio frequency

ARTG entry for

Medical Device Included Class IIa

Sponsor

GE Healthcare Australia Pty Ltd

Postal Address

PO Box 5079,PARRAMATTA DC, NSW, 2150

Australia

ARTG Start Date

13/03/2014

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

Medspira LLC

2718 Summer Street NE

Minneapolis, MN, 55413

United States Of America

Products

1. Coil, MRI, radio frequency

Product Type

Single Device Product

Effective date

13/03/2014

GMDN

40749 Coil, MRI, radio frequency

Intended purpose

The Medspira (formerly Mayo Clinic) BC-10 Transmit/Receive coil is a 12 leg,

high pass, quadrature design for high resolution musculoskeletal imaging.

The BC-10 MRI Coil is to be used with the GE Healthcare Solutions Signa 1.5T

and 3.0T type MRI scanners. The coil dimensions are approximately 10 cm

diameter and length, and can operate at frequencies associated with either 1.5T

or 3.0T proton based magnetic resonance imaging. The operating

frequency is established at construction via placement of

individual ceramic capacitors and can be identified by the part number on the

coil. This procedure is included in the service manual sent with each coil.

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 01:43:10 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

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

There are no news related to this product.