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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
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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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