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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
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Paul Biggins
Canon Medical Systems USA
2441 Michelle Drive
Tustin,  CA  90630
Correspondent Contact Orlando Tadeo
Regulation Number892.1750
Classification Product Code
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