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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 K151383
Device Name NeuViz 128 Multi-slice CT Scanner System
Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
NO.16, SHIJI ROAD, HUNNAN INDUSTRIAL AREA
SHENYANG,  CN 110179
Applicant Contact TIAN YUEHUI
Correspondent
NEUSOFT MEDICAL SYSTEMS CO., LTD.
NO.16, SHIJI ROAD, HUNNAN INDUSTRIAL AREA
SHENYANG,  CN 110179
Correspondent Contact TIAN YUEHUI
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/22/2015
Decision Date 11/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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