LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251937

    Validate with FDA (Live)

    Device Name
    nordicAudio (1.0)
    Manufacturer
    Nordicneurolab AS
    Date Cleared
    2026-03-20

    (269 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Age Range
    4 - 120
    Reference & Predicate Devices
    K232680
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The nordicAudio allows auditory signals from a source in the control room to enter the Magnet room and to be presented to the subject. The system consists of headphones connected through an access point. From this unit the system is connected to an audio hub unit in the control room, through a fiber cable. Standard audio sources can be connected to the audio hub and by this bring the audio to the subject.

    Indications for use

    The device is used to present audio to a subject during an MRI examination. It also facilitates communication between the operator and subject during the examination. The nordicAudio is intended to be used by trained professionals within the MRI environment.

    Device Description

    nordicAudio is an MR conditional audio System used to reduce acoustic noise, present auditory stimuli and enable subject operator communication during MR imaging.

    nordicAudio consisting of an MR compatible headset with optical data transmission, Battery unit for powering the headphones, Audio Hub for interfacing between commercial audio and optical transmission to headset.

    The device shall be deigned to fit into commonly used head coils from the main OEMs and provide noise attenuation during common MRI sequences.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1