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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 K091195
Model 9896 056 56511
Device Name PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland,  OH  44143
Original Contact michael chilbert
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/23/2009
Decision Date 05/27/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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