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510(k) Data Aggregation

    K Number
    K191278
    Device Name
    RSI-MRI+
    Date Cleared
    2019-11-19

    (190 days)

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

    MultiModal Imaging Services Corporation (dba HealthLytix)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusionweighted and anatomical magnetic resonance imaging data. RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images. RSI-MRI+ is additionally intended to provide automatic prostate segmentation, and reporting of derived image metrics. RSI-MRI+ is not intended for use in pediatric populations. RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions. RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices.
    Device Description
    RSI-MRI+ is standalone software that is used by radiologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical T2weighted MR images. Some of the features of RSI-MRI+ include: - Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps. - Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series. - Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (Al) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Seqmentation Series. - Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image. - Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software.
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