Certificates & Conformance Statements

Certified Operations

KaVo™, Instrumentarium Dental™ and SOREDEX™ operate according to the following international standards and directives.Our quality assurance complies with these certificate standards, and with the laws and requirements in the United States, Europe, Canada, Japan, China and Brazil. Our products are approved and registered globally. The testing and monitoring of our products is always performed adhering to the standards. Our business operations are monitored and audited by authorities and facilities for healthcare product technology around the world.

PDF icon DEKRA Certificate EN ISO 9001

Kaltenbach & Voigt GmbH

01.10.2018

PDF iconDEKRA Certificate 93/42/EC.pdf

Kaltenbach & Voigt GmbH

01.10.2018

PDF iconDEKRA Certificate EN ISO 13485.pdf

Kaltenbach & Voigt GmbH

01.10.2018

PDF iconDEKRA ISO 13485 (CMDCAS).pdf

Kaltenbach & Voigt GmbH

10.01.2013

PDF iconDirective 93/42/EEC.pdf
(Medical Devices Directive)

PaloDEx Group OY*

04.12.2020

PDF iconISO 13485:2003

Instrumentarium Dental/PaloDEx Group OY*

02.19.2019

PDF iconISO 9001:2008

Instrumentarium Dental/PaloDEx Group OY*

09.14.2018

PDF iconISO 14001:2004 
(Environmental Management System Certification)

Instrumentarium Dental/PaloDEx Group OY*

01.31.2018

PDF iconCE Certificate: Directive 93/42/EEC

SOREDEX/PaloDEx Group OY*

12.04.2020

PDF iconISO 13485 & 9001 Certificate

SOREDEX/PaloDEx Group OY*

02.28.2019

PDF iconISO 14001:2004 Certificate

SOREDEX/PaloDEx Group OY*

01.31.2018

*The  PaloDEx Group OY (auxiliary SOREDEX, PaloDEx Group OY and Instrumentarium Dental, PaloDEx Group OY) quality management system complies with US law 21 CFR part 820 (Quality System Regulation).

DICOM Conformance Statements

Statements

Company

PDF iconCLINIVIEW™  DICOM Conformance Statement

Instrumentarium Dental

PDF iconInvivo DICOM Conformance Statement

Anatomage

PDF iconSCANORA™ DICOM Conformance Statement

SOREDEX

PDF iconVixWin™ Platinum DICOM Conformance Statement

Gendex


Scope and Field of Application

The scope of this DICOM Conformance Statement is to facilitate data exchange with imaging equipment and dental imaging software. This document specifies the compliance to the DICOM 3.0 standard. It contains a short description of the applications involved and provides technical information about the data exchange capabilities of the equipment. The main elements describing these capabilities are: the supported DICOM Service Object Pair (SOP) Classes, Roles, Information Object Definitions (IOD) and Transfer Syntaxes.

The field of application is the integration of imaging equipment into an environment of other medical devices and hospital information systems. This Conformance Statement should be read in conjunction with the DICOM 3.0 standard and its addenda.


Intended Audience     

These conformance statements are intended for:

  1. System integrators of medical equipment
  2. Software designers implementing DICOM interfaces
  3. DICOM conformance testing and verification.

It is assumed that the reader is familiar with the DICOM 3.0 standard. Readers wishing to obtain more familiarity with the content and terminology of DICOM 3.0 standard are encouraged to obtain and review the standard, prior to reading this Conformance Statement. More information on acquiring this document and its updates on the DICOM standard may be found on the website of the National Electrical Manufacturer'sAssociation (NEMA) at www.nema.org.