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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
Canon Medical Systems Corporation
1385 Shimoishigami
otawara-shi,  JP 324-8550
Applicant Contact paul biggins
Canon Medical Systems USA, Inc.
2441 Michelle Drive
tustin,  CA  92780
Correspondent Contact orlando tadeo, jr.
Regulation Number892.1750
Classification Product Code
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