Combination diagnostic imaging system, PET/CT

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

Buy It Now

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

Public Summary

Summary for ARTG Entry:


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

ARTG entry for

Medical Device Included Class IIb


Philips Electronics Australia Ltd

Postal Address

Locked Bag 30,NORTH RYDE BC, NSW, 1670


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- 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.




Philips Medical Systems Nederland BV

Veenpluis 4-6

, PC Best, 5684



1. Combination diagnostic imaging system, PET/CT

Product Type

Single Device Product

Effective date



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

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 for contact information

Search alerts related to this product

Share this information