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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 K160932
Device Name 8ch Foot Ankle Coil
Shenzhen RF Tech Co., Ltd.
2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming
Shenzhen,  CN 518132
Applicant Contact Ke Xi
Shenzhen Joyantech Consulting Co., Ltd.
Room 1122, International Mayors Communication Centre
Shenzhen,  CN 518000
Correspondent Contact Elena Lu
Regulation Number892.1000
Classification Product Code
Date Received04/04/2016
Decision Date 08/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No