Picture

Main information

  • Trade name:
  • Picture archiving and communication system, radiology
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Picture archiving and communication system, radiology
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219250
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219250

AGFA HealthCare Australia - Picture archiving and communication system, radiology

ARTG entry for

Medical Device Included Class IIa

Sponsor

AGFA HealthCare Australia

Postal Address

PO Box 9149,SCORESBY, VIC, 3179

Australia

ARTG Start Date

15/01/2014

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

Agfa HealthCare N.V

Septestraat 27

Mortsel, , 2640

Belgium

Products

1. Picture archiving and communication system, radiology

Product Type

Single Device Product

Effective date

15/01/2014

GMDN

35719 Picture archiving and communication system, radiology

Intended purpose

The IMPAX Agility Solution will provide to qualified healthcare professionals a method to store, display,

review and

distribute medical images; to display, review, enter and edit the associated study information and to create,

edit, store

and distribute reports.

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 08:06:58 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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