K-number	K203314
Device name	Cartesion Prime (PCD-1000A/3) V10.8
Applicant	Canon Medical Systems Corporation
Product code	KPS
Device class	Class II
Decision date	Apr 23, 2021
Decision	Substantially Equivalent
Regulation	892.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Cartesion Prime (PCD-1000A/3) V10.8

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