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510(k) Data Aggregation

    K Number
    K201141
    Device Name
    FIRMM
    Manufacturer
    Date Cleared
    2020-08-26

    (119 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nous Imaging, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nous FIRMM system is an accessory to an MRI scanner to calculate and display patient motion during a head scan. The motion results are derived from the MR image data as it is being acquired. MR images can be imported during the scan, and analyzed to detect patient motion in real-time. FIRMM enables the operator to become aware of patient motion during the scanning session and can be used to support scanning efficiency. The device is intended for prescription use only.
    Device Description
    The company has developed a software-based system that performs Framewise Integrated Real-time MRI Monitoring (FIRMM®). The FIRMM system continuously monitors the MR image data as it is being generated during the exam to detect small displacements (rotation or translation) of the anatomy along any axis during MRI acquisitions of time series datasets. It quantifies these movements and provides the MRI scanner operator with a plot of patient motion displayed as type of 'seismograph', as well as providing a figure of overall motion quality. This system allows for non-invasive, non-contact monitoring of patient motion during brain MRIs, and displays motion metrics in real-time to the scanner operator, with an optional ability to provide biofeedback to the patient.
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