Vendor
7 FDA-cleared listings in this directory.
Claim vendor profileTherapixel
Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
Therapixel
MammoScreen BD evaluates 2D mammography standard views (CC and/or MLO) from compatible FFDM and/or 2D synthetic mammography from DBT to assign an ACR BI-RADS 5th Edition...
Therapixel
Identifies calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; it is not a standalone diagnostic device.
Therapixel
Adjunctively assess breast tissue composition and provide an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening...
Therapixel
Concurrent reading and reporting aid for physicians interpreting screening mammograms on compatible full-field digital mammography and digital breast tomosynthesis systems,...
Therapixel
MammoScreen is intended for use as a concurrent reading aid for interpreting physicians, to help identify findings on screening FFDM or DBT acquired with compatible mammography...
Therapixel
MammoScreen is a concurrent reading aid for interpreting physicians reviewing screening full-field digital mammography; it marks suspicious soft-tissue lesions and calcifications...