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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 K240301
Device Name MammoScreen® (3)
Applicant
Therapixel
455 Promenade des Anglais
Nice,  FR 06200
Applicant Contact Quentin De Snoeck
Correspondent
Therapixel
455 Promenade des Anglais
Nice,  FR 06200
Correspondent Contact Quentin De Snoeck
Classification Product Code
QDQ  
Subsequent Product Code
QIH  
Date Received02/01/2024
Decision Date 08/01/2024
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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