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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 K120525
Device Name QLAB QUANTIFICATION SOFTWARE
Original Applicant
PHILIPS HEALTHCARE GROUP
3000 minuteman road
andover,  MA  01810 -7324
Original Contact penny greco
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/22/2012
Decision Date 03/09/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party Yes
Combination Product No
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