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510(k) Data Aggregation

    K Number
    K232644
    Device Name
    neuro42 MRI System
    Manufacturer
    Date Cleared
    2024-02-08

    (162 days)

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

    Neuro42, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, the images can provide diagnostically useful information.
    Device Description
    neuro42 MRI System is a low-field MR system intended to be used for neuroimaging. The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device intended to be used for producing images that display the internal structure of the head. The device is a low-field magnetic resonance system and includes a movable magnet cart on wheels connected to a separate electronic cabinet on wheels. The system utilizes a permanent Halbach magnet array and does not require any external shielding.
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