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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 K092237
Device Name NSM-S15 SYSTEM
Applicant
Neusoft Medical Systems Co., Ltd.
#3-11, Wenhua Rd.
Heping District
Shenyang, Liaoning,  CN 110004
Applicant Contact TIAN YUEHUI
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/23/2009
Decision Date 09/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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