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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 K231085
Device Name 1.5T HD T/R Knee Array (10-F34127)
Applicant
Shenzhen RF Tech Co., Ltd.
2-F,Bld4 Juhui Industrial Park,Tianliao,Guangming,P.R.China
Shenzhen,  CN 518132
Applicant Contact Wang Gary
Correspondent
Shenzhen RF Tech Co., Ltd.
2-F,Bld4 Juhui Industrial Park,Tianliao,Guangming,P.R.China
Shenzhen,  CN 518132
Correspondent Contact Wang Gary
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/17/2023
Decision Date 08/18/2023
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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