Cartesion Prime (PCD-1000A/3) V10.8— 510(k) K203314

Substantially Equivalent

Canon Medical Systems Corporation

FDA 510(k) clearance K203314 for Cartesion Prime (PCD-1000A/3) V10.8, Substantially Equivalent on 2021-04-23. Applicant: Canon Medical Systems Corporation.

Clearance details

Applicant: Canon Medical Systems Corporation
Product code: Code KPS
Advisory panel: Radiology
Date received: 2020-11-10
Decision date: 2021-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

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