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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 K113086
Device Name ACQA
Original Applicant
TEXAS MEDICAL IMAGING CONSULTANTS
4027 underwood st.
houston,  TX  77025
Original Contact tinsu pan
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received10/18/2011
Decision Date 01/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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