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