Intraoperative postoperative

Main information

  • Trade name:
  • Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216516
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216516

Carl Zeiss Pty Ltd - Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator

ARTG entry for

Medical Device Included Class IIa

Sponsor

Carl Zeiss Pty Ltd

Postal Address

PO Box 501,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

24/10/2013

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

Carl Zeiss Meditec AG

Goeschwitzer Strasse 51-52

Jena, , D-07745

Germany

Products

1. Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator

Product Type

Single Device Product

Effective date

24/10/2013

GMDN

59682 Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator

Intended purpose

The Flat Applicator is intended to supply a specified radiation dose during applications exclusively in

combination with the INTRABEAM System during intraoperative radiotherapy on a surgically exposed

surface or in a tumor bed, or during treatment of tumors on the body surface.

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

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Public Summary

Page 1 of

Produced at 02.12.2017 at 05:31:18 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