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

    neuropacs

    K Number: DEN240071 · Decision Apr 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    485

    Basic Information

    Device Name
    neuropacs
    K Number
    DEN240071
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.2000
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Automated Imaging Diagnostics, LLC
    Date Received
    December 4, 2024
    Decision Date
    April 3, 2026
    Product Code
    SHO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SHO Parkinsonian Syndrome Diagnostic Aid