# K080515: Fmri Hardware System

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab
- Decided: May 16, 2008 after 81 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K043290 (2005). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073099: Fmri Hardware System, Nordicneurolab (2007) Summary page 1.

## Most influential descendants
- K092253: Modification to Fmri Hardware System (2009), 3 descendants of its own
- K191032: fMRI Hardware System (2019), 2 descendants of its own
- K232680: fMRI Hardware System (2023), 1 descendant of its own
- K251937: nordicAudio (1.0) (2026), 0 descendants of its own
- K093336: Integrated Stimulus Delivery System Optimum and Premium (2010), 0 descendants of its own

## Recalls of this device
- Oct 28, 2017 · Class II · Z-2103-2018: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

## 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/K080515
Methodology: https://510kreport.com/methodology