# K251937: nordicAudio (1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab AS
- Decided: Mar 20, 2026 after 269 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K043290 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232680: fMRI Hardware System, Nordicneurolab AS (2023) Summary page 5.

## Indications for 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. 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. nordicAudio is intended to be used by subjects and operated by trained professionals such as radiographers or technologist performing functional, clinical or interventional MRI scans. The Headset is designed for children above the age of 4 years. The nordicAudio is intended to be used in functional, clinical or interventional MRI environment.

Source page: https://510kreport.com/device/K251937
Methodology: https://510kreport.com/methodology