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

    HALO AP Dx

    K Number: K232833 · Decision May 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    237

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    Basic Information

    Device Name
    HALO AP Dx
    K Number
    K232833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Indica Labs, Inc.
    Date Received
    September 13, 2023
    Decision Date
    May 7, 2024
    Product Code
    PSY
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PSY Whole Slide Imaging System

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