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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K092742
Device Name NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
Applicant
Neusoft Medical Systems Co., Ltd.
#3-11, Wenhua Rd.
Heping District
Shenyang, Liaoning,  CN 110004
Applicant Contact TIAN YANGFANG
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/08/2009
Decision Date 09/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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