K-number	K201933
Device name	ImagenSPECT 3.0
Applicant	Cardiovascular Imaging Technologies
Product code	KPS
Device class	Class II
Decision date	Aug 11, 2020
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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ImagenSPECT 3.0

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