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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 K253935
Device Name medXion NEXUS
Applicant
medXion Technologies, Inc.
2-12-27 Kodo
Adachi-Ku
Tokyo,  JP 1200013
Applicant Contact Kazuhito Tomii
Correspondent
medXion Technologies, Inc.
2-12-27 Kodo
Adachi-Ku
Tokyo,  JP 1200013
Correspondent Contact Kazuhito Tomii
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/09/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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