Workstation

Main information

  • Trade name:
  • Workstation, MRI system
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Workstation, MRI system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216783
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216783

Philips Electronics Australia Ltd - Workstation, MRI system

ARTG entry for

Medical Device Included Class 1

Sponsor

Philips Electronics Australia Ltd

Postal Address

Locked Bag 30,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

31/10/2013

Product category

Medical Device Class 1

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

Invivo Corporation

3545 SW 47th Avenue

Gainesville, FL, 32608

United States Of America

Products

1. Workstation, MRI system

Product Type

Single Device Product

Effective date

31/10/2013

GMDN

40940 Workstation, MRI system

Intended purpose

Device indicated for use in conjunction with an MR scanner, as an accessory to entertain the patient

during the performance of any MRI procedure. To be used in conjunction with a Magnetic Resonance

Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques,

such analysis that can be interpreted by a trained physician.

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 04:18:34 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