BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    BIOGRAPH One

    K Number: K253023 · Decision Jan 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    13
    Applicant Total
    4
    Review Days
    118

    Basic Information

    Device Name
    BIOGRAPH One
    K Number
    K253023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthineers AG
    Date Received
    September 19, 2025
    Decision Date
    January 15, 2026
    Product Code
    OUO
    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
    OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

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