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510(k) Data Aggregation

    K Number
    K193218
    Device Name
    Innovision Audio
    Manufacturer
    Innovere Medical Inc.
    Date Cleared
    2020-04-07

    (138 days)

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

    Innovere Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Innovision Audio system is intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.
    Device Description
    Innovision Audio is a wireless device intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The Innovision Audio system is intended to be used by healthcare professionals. Innovision Audio is a multi-component system comprised of a wireless patient pillow, wireless bridges (data relays), and a Console Unit (entertainment control centre).
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