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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 K173574
Device Name DenSeeMammo
39 rue Camille Desmoulins
Villejuif,  FR 94800
Applicant Contact Stephane Ragusa
50 Milk Street
16th Floor
Boston,  MA  02109
Correspondent Contact Valérie Hélin
Regulation Number892.2050
Classification Product Code
Date Received11/20/2017
Decision Date 06/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No