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

    Opulus™ Lymphoma Precision

    K Number: K243863 · Decision May 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    51
    Review Days
    164

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    Basic Information

    Device Name
    Opulus™ Lymphoma Precision
    K Number
    K243863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Molecular Systems, Inc.
    Date Received
    December 17, 2024
    Decision Date
    May 30, 2025
    Product Code
    QIH
    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
    QIH Automated Radiological Image Processing Software

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