for the manufacturer or his authorised representative in the European Community

Image Instruments GmbH
Annaberger Str. 240
D 09125 Chemnitz

Product, -group (class I with measuring function)

Software for the measurement of orofacial patient images
ONYX Ceph V.2

The notified Body SLG Prüf- und Zertifizierungs GmbH herewith confirms that the a.m. manufacturer underwent a procedure of conformity assessment.
The conformity assessment was performed according to Annex VI of the following directive:

Medical Device Directive 93/42/EEC

Following documents proof the assessment results:

Audit report SLG - AB011141
Document assessment report SLG - DB011141

Proof could be given that a Quality Assurance System according to the requirements of Annex VI, section 3 is implemented for final inspection / testing.
Observing all relevant CE-Directives and providing the Manufacturer´s CE-Declaration of Conformity the CE-Mark can be lablled.

This certificate is the result of sampling methods. The Quality Assurance System is in regular surveillance following Annex VI, section 4.
SLG´s Regulations of Certification are binding.

The certificate is valid until August 29, 2007.

 
Hartmannsdorf, September 10, 2002           signed by [U. Schult]