# K073099: Fmri Hardware System

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab
- Decided: Nov 20, 2007 after 18 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: 1 generation back to K043290 (2005). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043290: Mindstate Functional Data Acquisition Device, Version 1.0, Neurognostics, Inc. (2005) Summary page 3.

## Most influential descendants
- K080515: Fmri Hardware System (2008), 5 descendants of its own
- 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

## 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/K073099
Methodology: https://510kreport.com/methodology