Spectral-domain

Main information

  • Trade name:
  • Spectral-domain optical coherence tomography system
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Spectral-domain optical coherence tomography system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221681
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221681

Carl Zeiss Pty Ltd - Spectral-domain optical coherence tomography system

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

25/03/2014

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. Spectral-domain optical coherence tomography system

Product Type

Single Device Product

Effective date

25/03/2014

GMDN

58850 Spectral-domain optical coherence tomography system

Intended purpose

The product is intended to intraoperatively acquire high resolution OCT images of anterior and posterior

segment of the eye in real time. It enables the application of OCT functionality to an ophthalmic surgical

microscope and provides OCT image data to an assistance system. The product includes an interface for

remote control by an assistance system.

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 10.11.2017 at 12:16:46 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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