ISO 13485

ScandiDos Quality Management System is assessed and registered by Intertek Certification as conforming to ISO 13485:2016.

FDA

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

K151180 (Delta4 Phantom+)

K183606 (Delta4 Phantom+ MR)

K151426 (Delta4 Discover)

MDD Certificate

EC certificate

MDD Product List

Declaration of Conformity for Delta4 Discover

Declaration of Conformity for Delta4 Phantom+

DICOM Conformance statement

DICOM conformance statement for Delta4.