Certified Operations

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.

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