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

    Delivery Date AI

    K Number: DEN250007 · Decision Feb 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    331

    Basic Information

    Device Name
    Delivery Date AI
    K Number
    DEN250007
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.8200
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Ultrasound AI
    Date Received
    March 17, 2025
    Decision Date
    February 11, 2026
    Product Code
    SHE
    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
    SHE Radiological Software System For Delivery Date Prediction