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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 K093581
Model CT590 & CT580
Device Name DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
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 Received11/18/2009
Decision Date 04/19/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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