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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 K253242
Device Name LCD Monitor (C1216W, C822W, C821W)
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
15f, Bldg. 6, Hengda Shishang Huigu(East),
Fulong Rd., Dalang Subdistrict, Longhua
Shenzhen,  CN 518109
Applicant Contact Li Yafei
Correspondent
Shenzhen Beacon Display Technology Co., Ltd.
15f, Bldg. 6, Hengda Shishang Huigu(East),
Fulong Rd., Dalang Subdistrict, Longhua
Shenzhen,  CN 518109
Correspondent Contact Li Yafei
Regulation Number892.2050
Classification Product Code
PGY  
Date Received09/29/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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