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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
Applicant
GE MEDICAL SYSTEMS, LLC
3000 N GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact TRACEY ORTIZ
Correspondent
GE MEDICAL SYSTEMS, LLC
3000 N GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent 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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