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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 K201378
Device Name 3D Accuitomo 150N
Applicant
J. Morita USA, INC.
9 Mason
Irvine,  CA  92618
Applicant Contact Fujio Zushi
Correspondent
Fish & Richardson P.C.
1000 Maine Avenue, S.W., Suite 1000
Washington DC,  DC  20005
Correspondent Contact Keith A. Barritt
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Codes
JAK   MUH  
Date Received05/26/2020
Decision Date 02/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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