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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 K160355
Device Name CX20N(CX20PUX)
Applicant
Wide Corporation
12 Wongomae-Ro, Giheung-Gu
Yongin-Si,  KR 17086
Applicant Contact YeoJin Yun
Correspondent
Wide Corporation
12 Wongomae-Ro, Giheung-Gu
Yongin-Si,  KR 17086
Correspondent Contact YeoJin Yun
Regulation Number892.2050
Classification Product Code
PGY  
Date Received02/08/2016
Decision Date 04/07/2016
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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