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FDA-cleared K260780

HeartFocus

Deski

Authorized purpose: Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require qualified clinical interpretation.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2026-06-03
FDA-cleared K242807

HeartFocus (V.1.1.1)

Deski

Authorized purpose: HeartFocus v1.1.1 guides trained medical professionals in acquiring ten standard adult 2D transthoracic echocardiographic views using compatible ultrasound systems, with live probe guidance, image-quality feedback and recording assistance for subsequent clinical interpretation.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2025-04-04