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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 K121792
Device Name NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
Applicant
Neusoft Medical Systems Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLES MACK
Correspondent
Neusoft Medical Systems Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Correspondent Contact CHARLES MACK
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/28/2012
Decision Date 11/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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