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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, therapeutic, x-ray
510(K) Number K122951
Model 110
Device Name XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
Applicant
ICAD, INC.
98 spit brook road
suite 100
nashua,  NH  03062
Contact john a delucia
Regulation Number892.5900
Classification Product Code
JAD  
Date Received09/25/2012
Decision Date 01/17/2013
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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