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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
GE HEALTHCARE
3000 n. grandview blvd
waukesha,  WI  53188
Original Contact larry kroger
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/07/2005
Decision Date 03/10/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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