BEUDAMED
    Eu Mdr Eu Md Class 2a On The Market 🇨🇭 Switzerland

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    b-rayZ AG · 🇨🇭 Switzerland
    View on EUDAMED
    Devices (same UDI-DI)
    1
    Certificates
    0
    Countries
    10
    Notified Bodies
    0

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    Basic Information

    Primary DI
    07649991532027
    Basic UDI-DI Code
    7649991532bboxplus2xxEU
    Reference
    b-box plus (DANAI)
    Device Types
    None provided
    Regulation
    Eu Mdr
    Classification
    Eu Md Class 2a
    Status
    On The Market
    Manufacturer
    b-rayZ AG

    Additional Description

    b-box plus (DANAI) is an AI stand-alone software indicated for the classification of mammographic breast density and pathological alterations according to the Breast Imaging-Reporting and Data System (BI-RADS) catalogue of the American College of Radiology , and for evaluation of diagnostic quality of digital mammograms according to the PGMI-method .

    CND Nomenclature Codes

    Code Description
    V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Available In Countries

    🇦🇹 Austria 🇧🇪 Belgium 🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇫🇷 France 🇮🇹 Italy 🇱🇹 Lithuania 🇳🇱 Netherlands 🇳🇴 Norway

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