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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 K232166
Device Name PreXion3D Expedition
Applicant
PreXion Corporation
1-14-1, Kandasuda-cho
Chiyoda-ku,  JP 101-0041
Applicant Contact Kenji Tanaka
Correspondent
PreXion Corporation
1-14-1, Kandasuda-cho
Chiyoda-ku,  JP 101-0041
Correspondent Contact Kenji Tanaka
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/21/2023
Decision Date 09/08/2023
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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