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7 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Therapixel
Authorized purpose: Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
Therapixel
Authorized purpose: 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 breast-density category for asymptomatic women aged 40 years or older undergoing screening; it is adjunctive, not diagnostic, and patient management remains with the interpreting physician.
Therapixel
Authorized purpose: Identifies calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; it is not a standalone diagnostic device.
Therapixel
Authorized purpose: 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 mammography; it is not diagnostic.
Therapixel
Authorized purpose: Concurrent reading and reporting aid for physicians interpreting screening mammograms on compatible full-field digital mammography and digital breast tomosynthesis systems, optionally using compatible prior examinations; outputs are adjunctive and must not be the sole basis for patient-management decisions.
Therapixel
Authorized purpose: Concurrent reading aid for interpreting physicians reading screening FFDM or DBT, to identify findings and assess suspicion; it is not the sole basis for management.
Therapixel
Authorized purpose: MammoScreen is a concurrent reading aid for interpreting physicians reviewing screening full-field digital mammography; it marks suspicious soft-tissue lesions and calcifications and provides suspicion scores, while patient management is not based solely on the device.