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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 K211541
Device Name MammoScreen 2.0
Applicant
Therapixel
455 Promenade des Anglais
Nice,  FR 06200
Applicant Contact Quentin De Snoeck
Correspondent
Domecus Consulting Services LLC
1171 Barroichet Drive
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Classification Product Code
QDQ  
Date Received05/19/2021
Decision Date 11/26/2021
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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