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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K151403
Device Name Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) 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 Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/26/2015
Decision Date 11/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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