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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 K060052
Device Name GE LIGHTSPEED XTRA CT SCANNER SYSTEM
Original Applicant
GE MEDICAL SYSTEMS, LLC
3000 n. grandview blvd.
waukesha,  WI  53188
Original Contact glen e sabin
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
KPQ  
Date Received01/06/2006
Decision Date 04/19/2006
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
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