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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K041270
Device Name CT COLONOGRAPHY II
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS
3000 north grandview blvd.
w-400
waukesha,  WI  53188
Original Contact larry a kroger
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/12/2004
Decision Date 05/27/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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