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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 K193329
Device Name PreXion3D Explorer EX
Applicant
Prexion Corporation
1-14-1, Kandasuda-Cho
Chiyoda-Ku,  JP 101-0041
Applicant Contact Hiroaki Takahashi
Correspondent
Prexion Corporation
1-14-1, Kandasuda-Cho
Chiyoda-Ku,  JP 101-0041
Correspondent Contact Hiroaki Takahashi
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/02/2019
Decision Date 04/09/2020
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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