3D Accuitomo 150N

X-ray, Tomography, Computed, Dental

J. Morita USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for 3d Accuitomo 150n.

Pre-market Notification Details

Device IDK201378
510k NumberK201378
Device Name:3D Accuitomo 150N
ClassificationX-ray, Tomography, Computed, Dental
Applicant J. Morita USA, INC. 9 Mason Irvine,  CA  92618
ContactFujio Zushi
CorrespondentKeith A. Barritt
Fish & Richardson P.C. 1000 Maine Avenue, S.W., Suite 1000 Washington Dc,  DC  20005
Product CodeOAS  
Subsequent Product CodeJAK
Subsequent Product CodeMUH
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-26
Decision Date2021-02-18

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