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510(k) Data Aggregation

    K Number
    K221738
    Device Name
    NS-HGlio
    Manufacturer
    Neosoma Inc.
    Date Cleared
    2022-09-27

    (104 days)

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

    Neosoma Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NS-HGlio is intended for the semi-automatic labeling, visualization, and volumetric quantification of high-grade brain glioma (WHO grade 3 astrocytoma, WHO grade 4 astrocytoma and WHO grade 4 glioblastoma) from a set of standard MRI images of male or female patients 18 years of age or older who are known to have pathologically proven high-grade glioma. Volumetric measurements may be compared to past measurements if available. NS-HGlio is not to be used for primary diagnosis, and is intended to be used by qualified clinical personnel as an additional source of information and is not intended to be the sole diagnostic metric.
    Device Description
    NS-HGlio is a non-invasive software as a medical device (SaMD) tool intended for labeling, visualization, and volumetric quantification of high-grade brain gliomas for a population that has been pathologically diagnosed to have brain tumors. The device is used as a tool by clinicians in determining the patient's disease conditions on pre- and post-operative MRI images. The device is not used for primary diagnosis. NS-HGlio device takes as an input imported Digital Imaging and Communications in Medicine (DICOM) images of high-grade brain glioma acquired with standard brain tumor MRI protocols and uses a deep learning methodology to semi-automatically label the different subcomponents of the high-grade glioma. Results are displayed on a Neosoma viewing software. Optionally, the software connects to clinicians' applications (e.g., PACS).
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