# K232680: fMRI Hardware System

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab AS
- Decided: Dec 13, 2023 after 103 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: 5 generations back to K043290 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191032: fMRI Hardware System, Nordicneurolab AS (2019) Summary page 5.

## Most influential descendants
- K251937: nordicAudio (1.0) (2026), 0 descendants of its own

## Indications for use
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast. nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR imaging (fMRI) based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips. The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions. nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.

Source page: https://510kreport.com/device/K232680
Methodology: https://510kreport.com/methodology