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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 K192854
Device Name MammoScreen
Applicant
Therapixel
Village By Ca - Le Theseus, Rue Claude Daunesse
Valbonne,  FR 06560
Applicant Contact Quentin de Snoeck
Correspondent
Domecus Consulting Services, LLC
1171 Barroihet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Classification Product Code
QDQ  
Date Received10/04/2019
Decision Date 03/25/2020
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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