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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 K121517
Model D70035
Device Name VERSAVUE ENTERPRISE SUITE
Original Applicant
ICAD, INC.
98 spit brook road
suite 100
nashua,  NH  03062
Original Contact michael a patz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/22/2012
Decision Date 07/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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