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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 K082816
Device Name GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
Original Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha,  WI  53188
Original Contact steven kachelmeyer
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/25/2008
Decision Date 10/08/2008
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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