BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Eve Patient Positioner System

    K Number: K231612 · Decision May 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    340

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    Basic Information

    Device Name
    Eve Patient Positioner System
    K Number
    K231612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leo Cancer Care
    Date Received
    June 2, 2023
    Decision Date
    May 7, 2024
    Product Code
    JAI
    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
    JAI Couch, Radiation Therapy, Powered

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    Other Clearances by Leo Cancer Care

    K Number Device Name
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