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FDA-cleared K252482

CogNet AI-MT+

Medcognetics, Inc.

Authorized purpose: Prioritizes suspicious screening DBT examinations for MQSA interpreting physicians; every examination remains subject to full physician review.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2025-12-11
FDA-cleared K220080

CogNet QmTRIAGE

MedCognetics, Inc.

Authorized purpose: Passive exam-level notification and prioritization of suspicious findings in screening mammograms.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2022-09-29