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    K Number
    K193102
    Device Name
    MRIaudio PREM System with MRIview
    Manufacturer
    MRIaudio, Inc.
    Date Cleared
    2020-01-06

    (59 days)

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

    MRIaudio, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRIaudio PREM System with MRIview is intended to provide audio and visual entertainment to patients and facilitate patient communication in MRI environments up to, and including, 3.0 Tesla. The product is not intended for medical diagnosis or treatment. Technologist control units are intended to be used outside of the MRI scan room.
    Device Description
    The MRIaudio PREM System with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, direct communication, and hearing protection. With the addition of the MRIview technology, the system provides MRI patients with video and allows technologists to view the patient.
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