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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 K122241
Models K023518, K050366
Device Name IMAGEN3D
Original Applicant
CARDIOVASCULAR IMAGING TECHNOLOGIES
9755 ridge drive
lenexa,  KS  66219
Original Contact melanie hasek
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received07/27/2012
Decision Date 10/24/2012
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
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