K-number	K241312
Device name	TeraRecon Cardiac.Chambers.MR (1.0.0)
Applicant	Terarecon,Inc.
Product code	QIH
Device class	Class II
Decision date	Nov 5, 2024
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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TeraRecon Cardiac.Chambers.MR (1.0.0)

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