INTRABEAM

Main information

  • Trade name:
  • INTRABEAM Spherical Applicator - Intraoperative/postoperative therapeutic x-ray system spherical applicator
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • INTRABEAM Spherical Applicator - Intraoperative/postoperative therapeutic x-ray system spherical applicator
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217625
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217625

Carl Zeiss Pty Ltd - INTRABEAM Spherical Applicator - Intraoperative/postoperative therapeutic x-ray

system spherical applicator

ARTG entry for

Medical Device Included Class III

Sponsor

Carl Zeiss Pty Ltd

Postal Address

PO Box 501,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

21/11/2013

Product category

Medical Device Class III

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. INTRABEAM Spherical Applicator - Intraoperative/postoperative therapeutic x-ray system spherical

applicator

Product Type

Single Device Product

Effective date

21/11/2013

GMDN

59681 Intraoperative/postoperative therapeutic x-ray system spherical applicator

Functional description

The spherical spplicators are used in conjunction with the INTRABEAM system to deliver a prescribed

dose of radiation to the tumor bed or tumor margins during intracavity or intraoperative radiotherapy

treatments.

Intended purpose

The spherical spplicators are accessory items to the INTRABEAM system. They are used in conjunction

with the INTRABEAM system to deliver a prescribed dose of radiation to the tumor bed or tumor margins

during intracavity or intraoperative radiotherapy treatments.

Variant information

Diameter (mm) 1.5cm to 5cm

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 02.12.2017 at 05:30:30 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