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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K251370
Device Name Cartesion Prime (PCD-1000A/3) V10.21
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Orlando Tadeo, Jr.
Correspondent
Canon Medical Systems, USA
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact Yoshiaki Cook
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/02/2025
Decision Date 12/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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