BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Relu Cloud

    K Number: K252708 · Decision Apr 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    2
    Review Days
    226

    Basic Information

    Device Name
    Relu Cloud
    K Number
    K252708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Relu BV
    Date Received
    August 27, 2025
    Decision Date
    April 10, 2026
    Product Code
    QIH
    Advisory Committee
    Radiology
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QIH Automated Radiological Image Processing Software

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