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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 K160935
Device Name 8ch Foot Ankle Coil
Applicant
Shenzhen RF Tech Co., Ltd.
2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming
Shenzhen,  CN 518132
Applicant Contact Ke Xi
Correspondent
Shenzhen RF Tech Co., Ltd.
2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming
Shenzhen,  CN 518132
Correspondent Contact Ke Xi
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/04/2016
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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