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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 K153570
Device Name Axxent Electronic Brachytherapy System Model 110 XP 1200
Applicant
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Applicant Contact John DeLucia
Correspondent
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Correspondent Contact John DeLucia
Regulation Number892.5900
Classification Product Code
JAD  
Date Received12/14/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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