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510(k) Data Aggregation

    K Number
    K230913
    Device Name
    ANDI
    Date Cleared
    2023-07-25

    (116 days)

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

    Imeka Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ANDI is intended for display of medical images and other healthcare data. It includes functions for image review, basic measurements, planning, and visualization (MPR reconstructions), Modules are available for image processing and atlas-assisted visualization and segmentation, where an output can be generated for use by a system capable of reading DICOM image sets. ANDI is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white matter tracts. The information presented by ANDI is for measurement of brain white matter tracts only without making a prediction, diagnosis, or interpretation of brain health, It is the responsibility of the physician to review all clinical information associated with a patient in order to make a diagnosis and to determine next steps in the clinical care of the patient. Typical users of ANDI are medical professionals, including but not limited to neurologists and radiologists. ANDI should be used only as adjunctive information. The decision made by trained medical professionals will be considered final. It is not a diagnostic aid.
    Device Description
    ANDI is quantitative imaging software that extracts features from medical images to provide adjunctive information for use with the complete standard of care evaluation of the patient. The device processes diffusion weighted images using local (on a per-voxel basis) and global (for the whole brain) reconstruction algorithms, respectively called modeling, tractography, and white matter bundling, to map microstructural properties of the white matter. ANDI achieves its intended use by extracting white matter bundles that connect specific regions of the brain and then performing a microstructure analysis along those bundles. ANDI combines two families of features derived from diffusion Magnetic Resonance Imaging (dMRI) along with T1-weighted images as an auxiliary input to augment processing. T1-weighted imaging is a general imaging modality that highlights differences in tissue types (skull, cerebrospinal fluid, white / gray matter), whereas dMRI is sensitive to the direction of white matter structures, based on the movements of water protons. Combining information from these MRI types gives ANDI data needed to quantify and visualize local water diffusion properties and to map these microstructural properties of the white matter along specific white matter bundles. The ANDI analysis techniques provide quantitative insight into white matter microstructure, corresponding to the local environment of each neurological fiber population. The resulting report provides trained medical professionals with reference information as an adjunct to care. The information included in the report is intended to be used by the trained medical professionals as a comparison between a patient and a control population as well as a comparison to the subject himself, with an optional longitudinal comparison.
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