Skip to main content

DEXIS Conformance Statements

DEXIS, 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.

Certificates

Company

Valid Until
(yyyy.mm.dd)

 DEKRA Certificate 93/42/EC

Kaltenbach & Voigt GmbH

2023.10.01

DEKRA Certificate EN ISO 13485

Kaltenbach & Voigt GmbH

2021.10.01

DEKRA Certificate ISO 13485:2016

Kaltenbach & Voigt GmbH

2021.12.01

 EC Certificate

PaloDEx GroupOY*

2020.12.04

 ISO 14001:2004
(Environmental Management System Certification)

PaloDEx Group OY*

2021.01.31

 ISO 13485:2016

PaloDEx Group OY*

2022.01.10

 EC Certificate
(Medical Devices Directive)

Instrumentarium Dental

2020.12.04

 ISO 14001:2004 
(Environmental Management System Certification)

Instrumentarium Dental

2021.01.31

 EC Certificate

Soredex/PaloDEx Group OY*

2020.12.04

 ISO 13485 & 9001 Certificate

Soredex/PaloDEx Group OY*

2019.02.28

 ISO 14001:2004 Certificate

Soredex/PaloDEx Group OY*

2021.01.31

 EC Certificate

Dental Imaging Technologies Corporation

2020.02.10

 ISO 13485:2016

Dental Imaging Technologies Corporation

2022.11.03

*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

 CLINIVIEW™  DICOM Conformance Statement

Instrumentarium Dental

 SCANORA™ DICOM Conformance Statement

Soredex

 VixWin™ Platinum DICOM Conformance Statement

Gendex

 DEXIS™ DICOM Conformance Statement

DEXIS™

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:

  • System integrators of medical equipment
  • Software designers implementing DICOM interfaces
  • 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’s Association (NEMA) at www.nema.org.

HIPAA Statements

Statements

Company

 DEXIS™  HIPAA Statement

DEXIS™

 Dental Imaging Technologies Corporation

Dental Imaging Technologies Corporation