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

    Aperio AT2 DX System

    K Number: K190332 · Decision May 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    95

    Basic Information

    Device Name
    Aperio AT2 DX System
    K Number
    K190332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Leica Biosystems Imaging, Inc.
    Date Received
    February 14, 2019
    Decision Date
    May 20, 2019
    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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