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FDA-cleared K232331

InVision Precision LVEF (LVEF)

InVision Medical Technology Corporation

Authorized purpose: Assist sonographers and physicians in cardiac evaluation by providing an automated LVEF estimate from previously acquired transthoracic cardiac ultrasound images in patients aged 22 years and older.

Modality
Ultrasound
Anatomy
Heart, including the left ventricle
Decision
2024-04-25