Certificates

ISO 13485

ScandiDos Quality Management System is assessed and registered by Intertek Certification as conforming to ISO 13485:2012.

MDD Certificate

EC certificate

MDD Product List

 

Declaration of Conformity for Delta4 Discover

 

Declaration of Conformity for Delta4 Phantom+

 

FDA

Delta4 is registered in the FDA Premarket Notification database under registration number:

K151180 (Delta4 Phantom+)

K151426 (Delta4 Discover)

DICOM Conformance statement

DICOM conformance statement for Delta4.