K-number	K222593
Device name	TruPlan Computed Tomography (CT) Imaging Software
Applicant	Circle Cardiovascular Imaging, Inc.
Product code	LLZ
Device class	Class II
Decision date	Jan 18, 2023
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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TruPlan Computed Tomography (CT) Imaging Software

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