MammoScreen

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.

Pre-market Notification Details

Device IDK192854
510k NumberK192854
Device Name:MammoScreen
ClassificationRadiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Applicant Therapixel Village By CA - Le Theseus, Rue Claude Daunesse Valbonne,  FR 06560
ContactQuentin De Snoeck
CorrespondentCindy Domecus
Domecus Consulting Services LLC 1171 Barroihet Drive Hillsborough,  CA  94010
Product CodeQDQ  
CFR Regulation Number892.2090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-04
Decision Date2020-03-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B885MAML0 K192854 000

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