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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 K232835
Device Name Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems, USA
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Orlando Tadeo Jr
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/14/2023
Decision Date 04/02/2024
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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