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FDA-cleared K241038

Cardiac CT Function Software Application

Circle Cardiovascular Imaging

Authorized purpose: Assist qualified medical professionals in assessing and evaluating cardiac function from multi-phase, multi-slice cardiovascular CT angiography images.

Modality
CT/CTA
Anatomy
Heart and cardiovascular structures
Decision
2024-06-07
FDA-cleared K232661

Myocardial Strain Software Application

Circle Cardiovascular Imaging

Authorized purpose: Myocardial Strain Software Application provides qualitative and quantitative evaluation of cardiovascular MR images, including two-dimensional displacement, velocity, strain, strain rate, time to peak, and torsion after a qualified user confirms the contours.

Modality
MRI
Anatomy
Heart; left ventricular myocardium and cardiovascular structures
Decision
2023-12-07