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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