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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 K072205
Device Name VISAGE PACS/CS, RELEASE VERSION 5.0
Original Applicant
MERCURY COMPUTER SYSTEMS, INC
beim strohhause 27
hamburg,  DE 20097
Original Contact martin gabler
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/08/2007
Decision Date 08/29/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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