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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 K051586
Device Name VIEWSEND MEDICAL SYSTEM
Applicant
Kenei Co., Ltd.
6899 Churchill Rd.
Mclean,  VA  22101
Applicant Contact JENNIFER LI
Correspondent
Kenei Co., Ltd.
6899 Churchill Rd.
Mclean,  VA  22101
Correspondent Contact JENNIFER LI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/15/2005
Decision Date 08/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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