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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 K260714
Device Name MammoScreen® (5)
Applicant
Therapixel
455 Promenade Des Anglais – 06200 Nice - France
Nice,  FR 06200
Applicant Contact Shalyna Long Bansropun
Correspondent
Therapixel
455 Promenade Des Anglais – 06200 Nice - France
Nice,  FR 06200
Correspondent Contact Shalyna Long Bansropun
Classification Product Code
QDQ  
Subsequent Product Code
QIH  
Date Received03/05/2026
Decision Date 06/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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