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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 K201836
Device Name Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
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  90630
Correspondent Contact orlando tadeo
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/02/2020
Decision Date 01/12/2021
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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