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Register entry

Cortex Diagnostics B.V.

Utrecht, Netherlands · Medical artificial intelligence

Certificates held

This organisation holds 1 certificate in force. Each applies only within the scope stated on it.

EDCA-2025-AC-0005

AI Governance Certification

EDCA Advanced Compliance — Level III

valid

Scope
Governance of the Cortex radiology triage system, covering intended purpose and limitations, training data provenance, clinician oversight, evaluation of accuracy and post-market monitoring.
Standard
EDCA-STD-05 v1.1
Issued
27 February 2025
Valid until
27 February 2028

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Inclusion in this register indicates that the Agency has assessed the organisation within the scope stated on each certificate. It is not an endorsement of the organisation, its products or its services, and says nothing about matters outside that scope.