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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 K090173
Device Name NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no.3-11, wenhua road
heping district
shenyang, liaoning,  CN 110004
Applicant Contact tian yanfang
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 commerce rd.
newton,  CT  06470
Correspodent Contact tamas borsai
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/23/2009
Decision Date 02/05/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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