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510(k) Data Aggregation

    K Number
    K223875
    Device Name
    MOBINEURO Alita Intraoperative MRI System
    Date Cleared
    2023-03-20

    (87 days)

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

    Sino Canada Health Engineering Research Institute (Hefei)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MOBINEURO Alita Intraoperative MRI System is indicated for use for the head and whole body. The MOBINEURO Alita Intraoperative MRI System is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. Correspond to the distribution of protons exhibiting MR characteristics; 2. Depend on NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and 3. Display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The MOBINEURO Alita Intraoperative MRI System will also be used during intraoperative procedures when performed in an intraoperative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment. The MOBINEURO Alita Intraoperative MRI System will also be used in a multi-room suite.
    Device Description
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