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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 K131299
Device Name ANYTHINK PACS WORKSTATION
Applicant
Beijing Crealife Technology Co., Ltd.
Rm. 519, Huitong Commerce
Bldg., B 20 Fuxing Rd.
Beijing,  CN 100036
Applicant Contact WEIHUA ZHOU
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/07/2013
Decision Date 05/22/2013
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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