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

    X9 Ultrasound System

    K Number: K251673 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    140

    Basic Information

    Device Name
    X9 Ultrasound System
    K Number
    K251673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    X9, Inc.
    Date Received
    May 30, 2025
    Decision Date
    October 17, 2025
    Product Code
    SGH
    Advisory Committee
    Radiology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SGH Ultrasound Imaging For Vascular Access For Hemodialysis