Workstation

Main information

  • Trade name:
  • Workstation, picture archiving and communication system
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Workstation, picture archiving and communication system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222753
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222753

Inline Systems Pty Ltd - Workstation, picture archiving and communication system

ARTG entry for

Medical Device Included Class 1

Sponsor

Inline Systems Pty Ltd

Postal Address

1/8 Prosperity Parade,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

24/04/2014

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

Foresight Imaging LLC

1 Executive Drive Suite 102

Chelmsford, MA, 01824

United States Of America

Products

1. Workstation, picture archiving and communication system

Product Type

Medical device system

Effective date

24/04/2014

GMDN

40943 Workstation, picture archiving and communication system

Intended purpose

T.I.M.S receives image data, acquired from various sources, including but not limited to CT,MR, US,

nuclear digital angiography and flurography, secondary capture devices, scanners or other imaging

sources. Images and data can be viewed, stored, transmitted, processed at the workstation, physician's

desktop or other clinical application and distributed across networks or the wed for viewing

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 07:54:53 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