Spectralis

Main information

  • Trade name:
  • Spectralis OCT + OCT Plus - Optical Coherence Tomograph - Microscope, laser optical scanning
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Spectralis OCT + OCT Plus - Optical Coherence Tomograph - Microscope, laser optical scanning
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222612
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222612

Heidelberg Engineering Pty Ltd - Spectralis OCT + OCT Plus - Optical Coherence Tomograph -

Microscope, laser optical scanning

ARTG entry for

Medical Device Included Class IIa

Sponsor

Heidelberg Engineering Pty Ltd

Postal Address

404 Albert Street,EAST MELBOURNE, VIC, 3002

Australia

ARTG Start Date

17/04/2014

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

Heidelberg Engineering GmbH

Max-Jarecki-Strasse 8

, Heidelberg, 69115

Germany

Products

1. Spectralis OCT + OCT Plus - Optical Coherence Tomograph - Microscope, laser optical scanning

Product Type

Medical device system

Effective date

17/04/2014

GMDN

36225 Microscope, laser optical scanning

Intended purpose

The Spectralis is an ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment

of the eye, including cross-sectional imaging, fundus photography, fluorescence imaging and to perform

measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection

and management of various ocular diseases. The Spectralis HRA+OCT include a retinal nerve fibre layer

thickness normative database, which is used to quantitively compare the retinal nerve fibre layer in the

human retina to a database of normal subjects.

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 09.11.2017 at 08:52:16 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