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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 K253596
Device Name Aquilion ONE (TSX-308A/TSX-306A) V2.0
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 Number892.1750
Classification Product Code
JAK  
Date Received11/18/2025
Decision Date 05/20/2026
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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