LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    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.
    Ask a Question

    Ask a specific question about this device

    K Number
    K180100
    Device Name
    MRIaudio PREM System
    Manufacturer
    MRIaudio
    Date Cleared
    2018-06-14

    (149 days)

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

    MRIaudio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRlaudio PREM system is intended to provide audio entertainment 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 is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1