# K191032: fMRI Hardware System

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab AS
- Decided: Nov 27, 2019 after 223 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: 4 generations back to K043290 (2005). 4 ancestors in all.
2 later devices descend 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)
- K092253: Modification to Fmri Hardware System, Nordicneurolab (2009) Summary page 4.

## Most influential descendants
- K232680: fMRI Hardware System (2023), 1 descendant of its own
- 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.

Source page: https://510kreport.com/device/K191032
Methodology: https://510kreport.com/methodology