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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radiological computer assisted detection/diagnosis software for lesions suspicious for cancer
510(k) Number K182373
Device Name PowerLook Tomo Detection V2 Software
Applicant
iCAD Inc.
98 Spitbrook 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 Number892.2090
Classification Product Code
QDQ  
Date Received08/31/2018
Decision Date 12/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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