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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K113483
Device Name ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
Original Applicant
PHILIPS HEALTHCARE (CLEVELAND)
595 miner rd.
cleveland,  OH  44143
Original Contact christine anderson
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/23/2011
Decision Date 09/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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