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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 K243679
Device Name MammoScreen® (4)
Applicant
Therapixel
455 Promenade Des Anglais
Nice,  FR 06200
Applicant Contact Pierre Fillard
Correspondent
MCRA an IQVIA Business
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Alex Cadotte
Classification Product Code
QDQ  
Subsequent Product Code
QIH  
Date Received11/29/2024
Decision Date 07/03/2025
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		 Yes
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