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510(k) Data Aggregation

    K Number
    K240793
    Device Name
    MSKai
    Manufacturer
    Date Cleared
    2024-12-16

    (269 days)

    Product Code
    Regulation Number
    892.2050
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    Applicant Name (Manufacturer) :

    MSKai

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MSKai is an image identification, post-processing, measurement, and reporting software tool that provides qualitative viewing and quantitative spine measurements from previously-acquired T2 weighted DICOM lumbar spine Magnetic Resonance Imaging (MRI) images for users' review, evaluation and analysis. It provides the following functionality to assist users in identifying, observing, measuring and reporting measurements: - Anatomy segmentation; - Anatomy labeling; - Anatomy measurement; and - Export of measurement results to a qualitative and quantitative report for user's evaluation, amendment and authorization MSKai does not serve as a diagnostic device by providing or recommending any type of medical diagnosis or treatment. MSKai simply provides users the ability to access objective and repeatable identification, segmentation, measurement and reported measurements of the Lumbar spine. The user is responsible for the indications of preferences and settings, confirming the software-generated measurements, and reviewing, confirming and approving draft reports based on their medical training. The device is intended to be used only by physicians, radiologist, hospitals and other medical institutions. Only T2 weighted DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are acceptable input. MSKai does not support DICOM images of patients that are pregnant, have post-operational complications, tumors, infections, or complex hardware.
    Device Description
    MSKai is a medical device (software) for inspecting and evaluating T2-weighted magnetic resonance imaging (MRI) of the lumbar spine. The software is an imaging interpretation tool that assists radiologists and neuro/ortho spine surgeons ("users") to identify and measure lumbar spine features in medical images and document their interpretations in a report. The segmentation and measurements are classified using "alerts" based on rule-based algorithms. The user also identifies and classifies any other observations that the software may not annotate.
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