ScandiDos Quality Management System is assessed and registered by Intertek Certification as conforming to ISO 13485:2016.
Delta4 is registered in the FDA Premarket Notification database under the registration numbers:
K151180 (Delta4 Phantom+)
K183606 (Delta4 Phantom+ MR)
K151426 (Delta4 Discover)
EC certificate
MDD Certificate EC certificate
MDD Product List
Declaration of Conformity for Delta4 Phantom+
Declaration of Conformity for Delta4 Discover
DICOM conformance statement for Delta4.
