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510(k) Data Aggregation

    K Number
    K251009
    Device Name
    Cirrus Resting State fMRI Software
    Date Cleared
    2025-06-06

    (66 days)

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

    Sora Neuroscience, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cirrus Resting State fMRI Software (Cirrus) is a software solution that performs magnetic resonance image processing including the processing of blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) data, resting state fMRI analysis, and output generation. Cirrus generates task-analogous motor, language, and vision resting state fMRI correlation maps, in DICOM® format for visualization and analysis external to Cirrus. Cirrus maps have been found to vary in normal subjects tested by repeat MR acquisition under conditions where no functional mapping change was expected. Medical imaging processing systems intended for BOLD fMRI post-processing are adjunctive and not intended to replace direct functional mapping procedures. Typical users of Cirrus are medical professionals, including but not limited to surgeons, radiologists, and other clinicians.
    Device Description
    Cirrus Resting State fMRI Software (Cirrus) is software as a medical device (SaMD) that performs image processing, resting state functional magnetic resonance imaging analysis, and output generation. Cirrus is launched by a host computing system external of Cirrus. Cirrus processes an individual patient's brain magnetic resonance imaging (MRI) dataset which includes blood oxygenation level dependent (BOLD) functional MRI (fMRI) data and structural MRI data. Software components making up Cirrus include (i) a suite of fMRI preprocessing tools; (ii) a voxel-wise resting state fMRI correlation map generator, (iii) a nonadaptive machine-learning based resting state network (RSN) membership scoring algorithm; and (iv) an RSN map output generator. The output of Cirrus is a set of patient-specific, task-analogous motor, language, and vision resting state fMRI correlation maps. The output maps correspond to three canonical, predefined brain resting state networks: - Sensorimotor network (SMN), - Language network (LAN), and - Vision network (VIS). Output resting state network maps are provided in DICOM® format for visualization and analysis external of Cirrus and accompanied by a quality report.
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