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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 K220986
Device Name Aquilion Precision (TSX-304A/4) V10.10 with AiCE
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
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/04/2022
Decision Date 09/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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