K-number	K232661
Device name	Myocardial Strain Software Application
Applicant	Circle Cardiovascular Imaging
Product code	LLZ
Device class	Class II
Decision date	Dec 7, 2023
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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Myocardial Strain Software Application

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