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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 K120709
Device Name THE DOME GX4MP COLOR NONITOR
Original Applicant
NDS SURGICAL IMAGING
5750 hellyer avenue
san jose,  CA  95138
Original Contact jim leng
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/2012
Decision Date 04/06/2012
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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