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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 K183186
Device Name Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/19/2018
Decision Date 02/08/2019
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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