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510(k) Data Aggregation

    K Number
    K202822
    Device Name
    Helianthus
    Manufacturer
    Metaltronica Spa
    Date Cleared
    2021-12-15

    (447 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    Metaltronica Spa

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Helianthus is intended to produce two dimensional digital mammographic images of the breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.
    Device Description
    Helianthus is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging. Helianthus is a digital mammography system also called full-field digital mammography (FFDM) system. It is an integrated system that includes both the X-ray delivery system and integrated detector. It consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. The image receptor system consists of a built-in full-filed solid state detector, acquisition software, acquisition work station (AWS), and accessories. It includes an optional stereotactic biopsy device (BYM 3D DMD) with its respective Operator's Manual. Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy
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