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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 K062451
Device Name NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
Original Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
no.3-11, wenhua road
heping district
shenyang, liaoning,  CN 110004
Original Contact tian yanfang
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/22/2006
Decision Date 09/28/2006
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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