X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital

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

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Philips Electronics Australia Ltd
Class 1
Authorization status:
Included (Export Only)
Authorization number:

Public Summary

Summary for ARTG Entry:


Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital

ARTG entry for

Medical Device Included (Export Only) Class 1


Philips Electronics Australia Ltd

Postal Address

Locked Bag 30,NORTH RYDE BC, NSW, 1670


ARTG Start Date


Product category

Medical Device Class 1



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. X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital

Product Type

Single Device Product

Effective date



37623 X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital

Intended purpose

Intended for use on human patients to perform: vascular, cardiovascular and neurovascular imaging

applications, including diagnostic, interventional anad minimally invasive procedures. Cardiac imaging

applications including diagnostics, interventional and minimally invasive procedures, pacemaker

implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and

vertebroplaties procedures.

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 04:37:58 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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