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510(k) Data Aggregation

    K Number
    K203509
    Device Name
    SMART FINDER
    Manufacturer
    IMS Giotto S.p.A.
    Date Cleared
    2021-07-14

    (226 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMS Giotto S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smart Finder is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
    Device Description
    Not Found
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    K Number
    K200424
    Device Name
    Giotto Class (Models - 3000X-YY and 4000X-YY)
    Manufacturer
    IMS GIOTTO S.p.A.
    Date Cleared
    2020-06-18

    (119 days)

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

    IMS GIOTTO S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device Giotto Class is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.
    Device Description
    Not Found
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