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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K251038
Device Name Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
Applicant
Shen Zhen Cambridge-Hit Co., Ltd.
1st Floor, Bldg. A1, Hualianfeng Bldg., Huaning Rd.
Dalang St., Longhua District
Shenzhen,  CN 51800
Applicant Contact Zhao Ming
Correspondent
Shenzhen Joyantech Consulting Co. , Ltd.
1713a, Block A, Zhongguan Times Square, Liuxian Ave.
Xili Town, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Fu Field
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2025
Decision Date 08/06/2025
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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