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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 K120161
Device Name ALPHAPOINT IMAGING SOFTWARE
Original Applicant
RADLOGICS, INC.
201 la canada court
los gatos,  CA  95023
Original Contact moshe becker
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/19/2012
Decision Date 04/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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