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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K260078
Device Name Aquilion ServeSP (TSX-307B) V2.0
Applicant
Canon Medical Systems Corporation
2441 Michelle Dr.
Tustin,  CA  92780
Applicant Contact Orlando Tadeo Jr
Correspondent
Canon Medical Systems, USA
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact Yoshiaki Cook
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/12/2026
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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