Combination diagnostic imaging system, PET/CT

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Philips Electronics Australia Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
324191

Public Summary

Summary for ARTG Entry:

324191

Philips Electronics Australia Ltd - Combination diagnostic imaging system, PET/CT

ARTG entry for

Medical Device Included Class IIb

Sponsor

Philips Electronics Australia Ltd

Postal Address

Locked Bag 30,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

27/09/2019

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

Philips Medical Systems Nederland BV

Veenpluis 4-6

, PC Best, 5684

Netherlands

Products

1. Combination diagnostic imaging system, PET/CT

Product Type

Single Device Product

Effective date

27/09/2019

GMDN

45143 Combination diagnostic imaging system, PET/CT

Intended purpose

A diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed

Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer

reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET

anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of

detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of

various diseases in oncology, cardiology, and neurology.

The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic,and

other major organs for a wide range of patient types, sizes, and extent of diseases.

Both subsystems can also be operated as fully functional, independent diagnostic tools, including

application of the CT scanner for diagnosis and for use in radiation therapy planning.

Specific Conditions

© 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 02.11.2019 at 03:30:48 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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