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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 Ave., SW, 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
Predetermined Change
Control Plan Authorized		 No
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