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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K110077
Device Name NEUCOLONCARE
Applicant
Neusoft Medical Systems Co., Ltd.
# 16, Shiji Rd.
Hunnan Indusrtial Area
Shenyang, Liaoning,  CN 110179
Applicant Contact TIAN YEUHUI
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/11/2011
Decision Date 01/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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