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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 K252876
Device Name GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only
Applicant
Shenzhen RF Tech Co., Ltd.
2-F,Bld4 Juhui Industrial Park,Tianliao, Guangming
Shenzhen,  CN 518132
Applicant Contact Gary Wang
Correspondent
Bonnier QM Consulting Center
Hailunxinyuan #3203, Jianghai District
Jiangmen,  CN 529000
Correspondent Contact Gary Wang
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/10/2025
Decision Date 04/01/2026
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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