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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 K252780
Device Name LCD Monitor (CL1902A, CL2103F)
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
15f, Bldg. 6, Hengda Shishang Huigu(East),
Fulong Rd., Dalang Subdistrict, Longhua
Shenzhen,  CN 518109
Applicant Contact Yafei Li
Correspondent
Shenzhen Beacon Display Technology Co., Ltd.
15f, Bldg. 6, Hengda Shishang Huigu(East),
Fulong Rd., Dalang Subdistrict, Longhua
Shenzhen,  CN 518109
Correspondent Contact Yafei Li
Regulation Number892.2050
Classification Product Code
PGY  
Date Received09/02/2025
Decision Date 12/19/2025
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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