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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 K181983
Device Name PreXion 3D Excelsior
Applicant
Prexion Corporation
1-14-1, Kandasuda-Cho
Chiyoda-Ku,  JP 101-0041
Applicant Contact Katsumi Hayashi
Correspondent
Prexion Corporation
1-14-1, Kandasuda-Cho
Chiyoda-Ku,  JP 101-0041
Correspondent Contact Katsumi Hayashi
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/25/2018
Decision Date 08/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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