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510(k) Data Aggregation

    K Number
    K212137
    Device Name
    X-Clever
    Manufacturer
    LG Electronics.Inc
    Date Cleared
    2021-12-10

    (155 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LG Electronics.Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, angiographic, and mammographic applications.)
    Device Description
    LG Acquisition Workstation Software ASHK100G is a diagnostic software for final post-processed X-ray images of body parts of actual patients acquired through the integration of digital X-ray detectors (DXDs) and X-ray generators. By integrating the [MWL] and the [PACS] server, this software can be used to check the information and images of the patients' body parts in real time in a HIS (Hospital Information System) based environment. A new image post-processing algorithm, MLP3 has been added to the proposed device. MLP3 provides image quality that is substantially equivalent to or slightly better than the predicate device even at lower x-ray dose levels. In addition, the functions have been added or modified to improve the user interface.
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