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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 K110227
Device Name OPTIMA CT660
Original Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha,  WI  53188
Original Contact tracey ortiz
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/25/2011
Decision Date 07/20/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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