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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K254092
Device Name Bellalun 2D (VDMS-1000S)
Applicant
Vieworks Co., Ltd.
41-3, Burim-Ro 170beon-Gil, Dongan-Gu
Anyang-Si,  KR 14055
Applicant Contact Seonghwan Park
Correspondent
Vieworks Co., Ltd.
41-3, Burim-Ro 170beon-Gil, Dongan-Gu
Anyang-Si,  KR 14055
Correspondent Contact Seonghwan Park
Regulation Number892.1715
Classification Product Code
MUE  
Date Received12/19/2025
Decision Date 05/28/2026
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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