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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
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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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