FDA-cleared K241430
EchoMeasure
iCardio.ai
Authorized purpose: Process previously acquired DICOM-compliant cardiac ultrasound images and make automated cardiac measurements to support qualified cardiologists, sonographers, or other licensed healthcare practitioners in adult clinical decision-making.
- Modality
- Ultrasound
- Anatomy
- Heart and cardiovascular structures
- Decision
- 2024-10-10