Cartesion Prime (PCD-1000A/3) V10.15— 510(k) K231748

Substantially Equivalent

Canon Medical Systems Corporation

FDA 510(k) clearance K231748 for Cartesion Prime (PCD-1000A/3) V10.15, Substantially Equivalent on 2023-09-12. Applicant: Canon Medical Systems Corporation.

Clearance details

Applicant: Canon Medical Systems Corporation
Product code: Code KPS
Advisory panel: Radiology
Date received: 2023-06-15
Decision date: 2023-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

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