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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K252587
Device Name HD 8Ch Wrist Array
Applicant
Shenzhen RF Tech Co., Ltd.
2-F,Bld4 Juhui Industrial Park,Tianliao, Guangming
Shenzhen,  CN 518132
Applicant Contact Wang Gary
Correspondent
Bonnier QM Consulting Center
Hailunxinyuan #3203, Jianghai District
Jiangmen,  CN 529000
Correspondent Contact Wang Gary
Regulation Number892.1000
Classification Product Code
MOS  
Date Received08/15/2025
Decision Date 04/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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