K-number	K202349
Device name	Cartesion Prime, PCD-1000A, V10.7
Applicant	Canon Medical Systems Corporation
Product code	KPS
Device class	Class II
Decision date	Oct 15, 2020
Decision	Substantially Equivalent
Regulation	892.1200

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View the full FDA submission: accessdata.fda.gov

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Cartesion Prime, PCD-1000A, V10.7

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