Cartesion Prime (PCD-1000A/3) V10.21— 510(k) K251370

Substantially Equivalent

Canon Medical Systems Corporation

FDA 510(k) clearance K251370 for Cartesion Prime (PCD-1000A/3) V10.21, Substantially Equivalent on 2025-12-01. Applicant: Canon Medical Systems Corporation.

Clearance details

Applicant: Canon Medical Systems Corporation
Product code: Code KPS
Advisory panel: Radiology
Date received: 2025-05-02
Decision date: 2025-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otawara-Shi, JP

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