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510(k) Data Aggregation

    K Number
    K241121
    Device Name
    MICSI-RMT
    Date Cleared
    2024-07-17

    (85 days)

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

    Microstructure Imaging, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MICSI-RMT is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head MRI.
    Device Description
    MICSI-RMT Denoising (MICSI-RMT) is a Software as a Medical Device (SaMD) intended to enhance magnetic resonance imaging (MRI) images by reducing the image noise for head MRI images. The software can analyze both functional (fMRI) MRI and diffusion (dMRI) images. The device is intended to be used by radiologists in an imaging center, clinic, or hospital. The device is compatible with DICOM 3.0 standard. The subject device has no user interface. The DICOM images obtained from a compatible MRI machine are streamed from the scanner to the designated DICOM destination, e.g., picture archiving and communication system (PACS), then to a DICOM router and processor (Mercure). It is within this router and processor where the subject device denoises the images. For fMRI images, parametric maps will be generated using pre-existing hospital software. For dMRI images, the subject device uses DTI to perform parameter estimation after denoising. Once the processing is complete, the device outputs are then routed to the target PACS (which can be the same one as before or a new DICOM destination) where the intended user can view the new images and the original images. Image processing time varies as it is dependent on the central processing unit (CPU), input imaqe size, and the number of input images. When multiple jobs have been submitted to MICSI-RMT, they are queued and processed sequentially based on the order received.
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