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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 K142465
Device Name Aquilion ONE Vision, 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 Received09/02/2014
Decision Date 03/10/2015
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
Recalls CDRH Recalls
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