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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 K173468
Device Name Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
Applicant
Toshiba Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Toshiba America Medical Systems, Inc
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Orlando Tadeo
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/08/2017
Decision Date 02/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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