510(k) Report

510(k) · Cleared

Cleared

fMRI Hardware System

K232680510(k) TraditionalCleared Dec 13, 2023103-day reviewClass II21 CFR 892.1000

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

Nordicneurolab AS · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Dec 13, 2023 as substantially equivalent to K191032 (Nordicneurolab AS, 2019) after a 103-day review. Its family tree reaches back 5 generations to 2005. 1 later device descends from it.

Decided
Dec 13, 2023
Review
103 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K043290 (2005). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2026: 1 descendant clearedK043290 · Mindstate Functional Data Acquisition Device, Version 1.0 · Neurognostics, Inc. · 2005K073099 · Fmri Hardware System · Nordicneurolab · 2007K080515 · Fmri Hardware System · Nordicneurolab · 2008 · recalledK092253 · Modification to Fmri Hardware System · Nordicneurolab · 2009 · recalledK191032 · fMRI Hardware System · Nordicneurolab AS · 201920052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K191032 · fMRI Hardware System · Nordicneurolab AS · 2019K092253 · Modification to Fmri Hardware System · Nordicneurolab · 2009 · recalledK080515 · Fmri Hardware System · Nordicneurolab · 2008 · recalledK073099 · Fmri Hardware System · Nordicneurolab · 2007K043290 · Mindstate Functional Data Acquisition Device, Version 1.0 · Neurognostics, Inc. · 2005−50
  1. Root · 5 generations backK043290 Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005
  2. 4 generations backK073099 Fmri Hardware SystemNordicneurolab · 2007
  3. 3 generations backK080515 Fmri Hardware SystemNordicneurolab · 2008 · Recalled
  4. 2 generations backK092253 Modification to Fmri Hardware SystemNordicneurolab · 2009 · Recalled
  5. 1 generation backK191032 fMRI Hardware SystemNordicneurolab AS · 2019
  6. This deviceK232680 fMRI Hardware SystemNordicneurolab AS · 2023
  7. Descendant · cites it directly · 0 of its ownK251937 nordicAudio (1.0)Nordicneurolab AS · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K251937nordicAudio (1.0)Nordicneurolab AS · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K043290Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc.2005—
−4K073099Fmri Hardware SystemNordicneurolab2007—
−3K080515Fmri Hardware SystemNordicneurolab20081
−2K092253Modification to Fmri Hardware SystemNordicneurolab20091
−1K191032fMRI Hardware SystemNordicneurolab AS2019—
0 (this device)K232680fMRI Hardware SystemNordicneurolab AS2023—
+1K251937nordicAudio (1.0)Nordicneurolab AS2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K232680, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

TypeNumberDeviceApplicantDecidedRecalls
*K191032fMRI Hardware System
Summary page 5
…Radiology Product Code: LNH Trade/Proprietary Name: fMRI Hardware System Predicate device name: fMRI Hardware System (K191032) NordicNeuroLab AS – Traditional 510(k) 510(k) Summary fMRI Hardware System (nordic…
Nordicneurolab AS2019—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K251937nordicAudio (1.0)Nordicneurolab AS20260

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K251937 (Nordicneurolab AS, 2026) has gone furthest, with 0 descendants of its own.

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. 2023, this device’s year, is highlighted.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
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

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

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. 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…

Read the full statement (149 words)

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.

Indications for use as stated in the FDA summary.

More from Nordicneurolab AS

7 FDA decisions under this applicant name. See the company

  • K251937nordicAudio (1.0)Nordicneurolab AS · 2026
  • K243209nordicMEDiVANordicneurolab AS · 2024
  • K241608nordicMEDiVANordicneurolab AS · 2024
  • K212720nordicDSCNordicneurolab AS · 2022
  • K191032fMRI Hardware SystemNordicneurolab AS · 2019

Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K232680 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232680: fMRI Hardware System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232680

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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