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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 K222719
Device Name CX50N
Applicant
Wide Corporation
15f, The First Tower Iii, 602, Dongtangiheung-Ro
Hwaseong-Si,  KR 18469
Applicant Contact YeoJin Yun
Correspondent
Ot Consulting, Inc.
33781 Bayside Ln.
Dana Point,  CA  92629
Correspondent Contact Josh Baker
Regulation Number892.2050
Classification Product Code
PGY  
Date Received09/08/2022
Decision Date 05/09/2023
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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