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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241561
Device Name MammoScreen BD
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
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/31/2024
Decision Date 10/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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