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FDA-cleared K220956

Libby Echo:Prio

Dyad Medical, Inc

Authorized purpose: Process previously acquired DICOM-compliant cardiac ultrasound images and estimate cardiac measurements to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in clinical decision-making; indicated for adults.

Modality
Ultrasound
Anatomy
Heart and cardiovascular structures, including LV chamber/endocardium, LA, and LV myocardium
Decision
2022-07-20