Empower

Main information

  • Trade name:
  • Empower Systems - Angiography contrast medium injection system, line-powered, stationary
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Empower Systems - Angiography contrast medium injection system, line-powered, stationary
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222366
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222366

Regional Health Care Group Pty Ltd - Empower Systems - Angiography contrast medium injection system,

line-powered, stationary

ARTG entry for

Medical Device Included Class IIb

Sponsor

Regional Health Care Group Pty Ltd

Postal Address

PO Box 151,ROSEBERY, NSW, 1445

Australia

ARTG Start Date

10/04/2014

Product category

Medical Device Class IIb

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

Bracco Injeneering S A

Avenue de Sevelin 46

, Lausanne, 1004

Switzerland

Products

1. Empower Systems - Angiography contrast medium injection system, line-powered, stationary

Product Type

Medical device system

Effective date

10/04/2014

GMDN

57998 Angiography contrast medium injection system, line-powered, stationary

Intended purpose

Intended to be used for controlled infusion of radiographic contrast media for angiographic procedures.

Used in conjunction with consumables such as syringe kits etc

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 09.11.2017 at 09:53:05 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

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We know that cancer is harder to find in women with dense breasts – some women may need other imaging tests. Breast density reporting is already required in some states. Expanding this nationwide will empower patients and providers to make more informed h

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