BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    RadiForce MX317W-PA

    K Number: K242545 · Decision May 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    29
    Review Days
    269

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    Basic Information

    Device Name
    RadiForce MX317W-PA
    K Number
    K242545
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eizo Corporation
    Date Received
    August 27, 2024
    Decision Date
    May 23, 2025
    Product Code
    PZZ
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PZZ Digital Pathology Display

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    Other Clearances by Eizo Corporation

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