BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    INFINITT DPS

    K Number: K243449 · Decision Dec 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    4
    Review Days
    397

    Basic Information

    Device Name
    INFINITT DPS
    K Number
    K243449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infinitt Healthcare Co., Ltd.
    Date Received
    November 7, 2024
    Decision Date
    December 9, 2025
    Product Code
    QKQ
    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
    QKQ Digital Pathology Image Viewing And Management Software

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