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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K260820
Device Name VIVIX-S 4386W (FXRD-4386WA)
Applicant
Vieworks Co., Ltd.
41-3, Burim-Ro 170beon-Gil, Dongan-Gu, Anyang-Si,
Gyeonggi-Do,  KR 14055
Applicant Contact Juin Lee
Correspondent
Vieworks Co., Ltd.
41-3, Burim-Ro 170beon-Gil, Dongan-Gu, Anyang-Si,
Gyeonggi-Do,  KR 14055
Correspondent Contact Juin Lee
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/13/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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