FDA-cleared K220956

Libby Echo:Prio

Dyad Medical, Inc

Process previously acquired DICOM-compliant cardiac ultrasound images and estimate cardiac measurements to support qualified cardiologists, sonographers, or other licensed...

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