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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
Model CMQ
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 (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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