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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 K180125
Device Name PowerLook Density Assessment Software
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 Number892.2050
Classification Product Code
LLZ  
Date Received01/16/2018
Decision Date 04/05/2018
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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