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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 K052839
Device Name CT PERFUSION 4
Original Applicant
3000 n. grandview blvd
waukesha,  WI  53188
Original Contact larry kroger
Regulation Number892.1750
Classification Product Code
Date Received10/07/2005
Decision Date 03/10/2006
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