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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
Original Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no.3-11, wenhua road
heping district
shenyang, liaoning,  CH 110004
Original Contact tian yangfang
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/08/2009
Decision Date 09/22/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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