MammoScreen 2.0

Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

Therapixel

The following data is part of a premarket notification filed by Therapixel with the FDA for Mammoscreen 2.0.

Pre-market Notification Details

Device IDK211541
510k NumberK211541
Device Name:MammoScreen 2.0
ClassificationRadiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Applicant Therapixel 455 Promenade Des Anglais Nice,  FR 06200
ContactQuentin De Snoeck
CorrespondentCindy Domecus
Domecus Consulting Services LLC 1171 Barroichet Drive Hillsborough,  CA  94010
Product CodeQDQ  
CFR Regulation Number892.2090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-19
Decision Date2021-11-26

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