K-number	K213998
Device name	cvi42 Auto Imaging Software Application
Applicant	Circle Cardiovascular Imaging, Inc.
Product code	QIH
Device class	Class II
Decision date	Jul 28, 2022
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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cvi42 Auto Imaging Software Application

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