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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K131896
Device Name SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
Applicant
SUZHOU ANKE MEDICAL SYSTEM CO., LTD
P.O. BOX 120-119
SHANGHAI,  CN 200120
Applicant Contact Diana Hong
Correspondent
SUZHOU ANKE MEDICAL SYSTEM CO., LTD
P.O. BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact Diana Hong
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/25/2013
Decision Date 02/28/2014
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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