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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K171012
Device Name Veraview X800
Applicant
J.Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Applicant Contact Keisuke Mori
Correspondent
Fish & Richardson P.C.
1425 K Street, N.W., Suite 1100
Washingon DC,  DC  20005
Correspondent Contact Keith A. Barritt
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received04/04/2017
Decision Date 12/19/2017
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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