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510(k) Data Aggregation

    K Number
    K071241
    Device Name
    LMS-LIVER
    Manufacturer
    MEDIAN TECHNOLOGIES
    Date Cleared
    2007-06-08

    (36 days)

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

    MEDIAN TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver is intended to be used by radiologists and other clinicians qualified to interpret CT images. LMS-Liver device is designed to be used with CT images covering the liver area in adult patients.
    Device Description
    LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. LMS-Liver can segment hepatic lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity. LMS-Liver can match and compare lesions present in two different datasets of the same patient acquired at different dates and compute their difference of size and volume.
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    K Number
    K070868
    Device Name
    LMS-LUNG/TRACK
    Manufacturer
    MEDIAN TECHNOLOGIES
    Date Cleared
    2007-05-15

    (47 days)

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

    MEDIAN TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to - visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user; - compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation) - generate automatic reports. LMS-Lung/Track device is designed to be used in diagnostic thoracic CT examinations in adult patients. LMS-Lung/Track is not intended to be used for patients with prior thoracotomy.
    Device Description
    LMS-Lung/TRACK provides visualization and analysis tools for chest CT images acquired in low or normal dose. LMS-Lung/TRACK segments pulmonary lesions identified by the user with a double click (seed point). Once a lesion is segmented, the software computes its characteristics such as size, volume and intensity. Alternatively, the user can do its own 2D measurements on the lesion. LMS-Lung/TRACK matches and compares lesions identified by the physician present in two different datasets of the same patient acquired at different dates. It computes the differences of volume and diameters and volume growth. LMS-Lung/Track provides tool to generate report with snapshots, and results.
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