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FDA-cleared K234141

AISAP Cardio V1.0

Aisap

Authorized purpose: AISAP CARDIO V1.0 automatically processes and analyzes acquired cardiac POCUS images and produces a report with diagnostic assessment and measurements, including selected valvular pathology, LVEF, ventricular dimensions, RV FAC, atrial areas, ascending-aorta diameter, and IVC diameter, to support qualified physicians using FDA-cleared ultrasound devices.

Modality
Ultrasound
Anatomy
Heart/cardiovascular structures
Decision
2024-08-01