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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 K080540
Device Name NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
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
Correspondent Contact TAMAS BORSAI
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/27/2008
Decision Date 03/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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