BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Helianthus

    K Number: K202822 · Decision Dec 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    447

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    Basic Information

    Device Name
    Helianthus
    K Number
    K202822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1715
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Metaltronica Spa
    Date Received
    September 24, 2020
    Decision Date
    December 15, 2021
    Product Code
    MUE
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUE Full Field Digital, System, X-Ray, Mammographic

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