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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 K083555
Device Name PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
Applicant
Emsoma Co., Ltd.
#302 Kang-Rim B/D,Sungnae-Dong
448-7, Gangdong-Gu
Seoul,  KR 134-030
Applicant Contact WEONBUM LEE
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/02/2008
Decision Date 12/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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