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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 K153263
Device Name Aquilion Lightning, TSX-035A/4 and /5, V7.0
Applicant
Toshibamedical Systems Corporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact PAUL BIGGINS
Correspondent
Toshiba America Medical Systems, In.C
2441 Michelle Dr.
Tustin,  CA  92780
Correspondent Contact ORLANDO TADEO
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/10/2015
Decision Date 04/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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