Nuclear

Main information

  • Trade name:
  • Nuclear medicine system, SPECT, application program software
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Nuclear medicine system, SPECT, application program software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221222
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221222

GE Healthcare Australia Pty Ltd - Nuclear medicine system, SPECT, application program software

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

GE Medical Systems SCS

283 rue de la Miniere

BP34, Buc Cedex, 78533

France

Products

1. Nuclear medicine system, SPECT, application program software

Product Type

Single Device Product

Effective date

13/03/2014

GMDN

40869 Nuclear medicine system, SPECT, application program software

Intended purpose

This software is intended for processing and reading non-cardiac volumetric data, including NM SPECT

and hybrid SPECT-CT, PET-CT, external CT/MR (CT/MR from a separate non-hybrid scan). For follow-up

studies, two studies can be registered and viewed simultaneously, each including its reference data.

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 01:42:54 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

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety