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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 K113754
Model VERISON 1.0
Device Name CFR QUANT
Original Applicant
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON
6431 fannin st.
room msb 4.256
houston,  TX  77030
Original Contact k. lance gould
Regulation Number892.1200
Classification Product Code
KPS  
Date Received12/30/2011
Decision Date 07/19/2012
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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