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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, tomography, computed, emission
510(k) Number K061587
Device Name FULLCARD ANALYSIS
Original Applicant
GE HEALTHCARE
3000 n. grandview blvd.
waukesha,  WI  53188
Original Contact larry a kroger
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/08/2006
Decision Date 06/23/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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