510(k) · Cleared

Recalled · Class II · 2018

Modification to Fmri Hardware System

K092253510(k) SpecialCleared Oct 8, 200972-day reviewClass II21 CFR 892.1000Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nordicneurolab · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 8, 2009 as substantially equivalent to K080515 (Nordicneurolab, 2008) after a 72-day review. Its family tree reaches back 3 generations to 2005. 3 later devices descend from it. It has been recalled once.

Decided: Oct 8, 2009
Review: 72 days
Class: Class II
Product code: LNH
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K043290 (2005). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK043290 Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005
2 generations backK073099 Fmri Hardware SystemNordicneurolab · 2007
1 generation backK080515 Fmri Hardware SystemNordicneurolab · 2008 · Recalled
This deviceK092253 Modification to Fmri Hardware SystemNordicneurolab · 2009
Descendant · cites it directly · 2 of its ownK191032 fMRI Hardware SystemNordicneurolab AS · 2019
Descendant · 2 generations on · 1 of its ownK232680 fMRI Hardware SystemNordicneurolab AS · 2023
Descendant · 3 generations on · 0 of its ownK251937 nordicAudio (1.0)Nordicneurolab AS · 2026

Most influential descendants

Showing 3 of 3 · See all

K191032fMRI Hardware SystemNordicneurolab AS · 2019 · cites it directly2descendants
K232680fMRI Hardware SystemNordicneurolab AS · 2023 · 2 generations on1descendant
K251937nordicAudio (1.0)Nordicneurolab AS · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K043290	Mindstate Functional Data Acquisition Device, Version 1.0	Neurognostics, Inc.	2005	—
−2	K073099	Fmri Hardware System	Nordicneurolab	2007	—
−1	K080515	Fmri Hardware System	Nordicneurolab	2008	1
0 (this device)	K092253	Modification to Fmri Hardware System	Nordicneurolab	2009	—
+1	K191032	fMRI Hardware System	Nordicneurolab AS	2019	—
+2	K232680	fMRI Hardware System	Nordicneurolab AS	2023	—
+3	K251937	nordicAudio (1.0)	Nordicneurolab AS	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K092253, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K080515	Fmri Hardware System Summary page 1 …Fax: +47 55 70 70 96 E-mail: [email protected] Legally marketed Device name and 510(k) number: fMRI Hardware System. K080515 Modified Device Name fMRI Hardware System Device Common Name: Accessory to MRI System, Nuclear Magnetic R…	Nordicneurolab	2008	1

Also cleared against K080515: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K191032	fMRI Hardware System	Nordicneurolab AS	2019	2

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 20, 2018	Class II	Z-3023-2018	Labeling design	Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K191032 (Nordicneurolab AS, 2019) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K080515.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092253 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092253: Modification to Fmri Hardware System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092253

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026