Certificates

 

 
ISO 13485
ScandiDos Quality Management System is assessed and registered by Intertek Certification as conforming to ISO 13485:2003 Download
 
Declaration of Conformity
Declaration of conformity for Delta4. Download
 
MDD Certificate
Quality system certificate Download
 
FDA
Delta4 is registered in the FDA Premarket Notification database under registration number: K052920
 
Link to FDA
DICOM Conformance statement
DICOM conformance statement for Delta4. Download document here. Download