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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name display, diagnostic radiology
510(k) Number K222716
Device Name MX50N
WIDE Corporation
15F, The First Tower III, 602, Dongtangiheung-Ro
Hwaseong-Si,  KR 18469
Applicant Contact YeoJin Yun
OT Consulting
33781 Bayside Lane
Dana Point,  CA  92629
Correspondent Contact Josh Baker
Regulation Number892.2050
Classification Product Code
Date Received09/08/2022
Decision Date 05/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No