FDA-cleared K241245
EchoSolv AS
Echo IQ Ltd
Authorized purpose: Adjunctive assessment of severe aortic stenosis using transthoracic echocardiography data; an interpreting physician uses the output to facilitate diagnosis and must not rely on it alone for patient management.
- Modality
- Ultrasound
- Anatomy
- Heart, left ventricular outflow tract, and aortic valve
- Decision
- 2024-10-04