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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 K183046
Device Name Aquilion ONE (TSX-305A/6) V8.9 with AiCE
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems USA, Inc.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Orlando Tadeo, Jr.
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/02/2018
Decision Date 06/12/2019
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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