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

    VerTouch Spinal Imaging Device

    K Number: DEN220009 · Decision Jan 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    717

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    Basic Information

    Device Name
    VerTouch Spinal Imaging Device
    K Number
    DEN220009
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.1985
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Intuitap Medical, Inc.
    Date Received
    February 1, 2022
    Decision Date
    January 19, 2024
    Product Code
    QXD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QXD Spinal Imaging System For Neuraxial Procedures