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

    MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)

    K Number: K242258 · Decision Nov 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    152
    Registration Numbers
    152
    Same Product Code
    1071
    Applicant Total
    1
    Review Days
    118

    Basic Information

    Device Name
    MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
    K Number
    K242258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ASG Superconductors S.P.A.
    Date Received
    July 31, 2024
    Decision Date
    November 26, 2024
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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