510(k) · Cleared
Recalled · Class II · 2017Fmri Hardware System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nordicneurolab · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 16, 2008 as substantially equivalent to K073099 (Nordicneurolab, 2007) after an 81-day review. Its family tree reaches back 2 generations to 2005. 5 later devices descend from it. It has been recalled once.
- Decided
- May 16, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K043290 (2005). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK043290 Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005
- 1 generation backK073099 Fmri Hardware SystemNordicneurolab · 2007
- This deviceK080515 Fmri Hardware SystemNordicneurolab · 2008
- Descendant · cites it directly · 3 of its ownK092253 Modification to Fmri Hardware SystemNordicneurolab · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK191032 fMRI Hardware SystemNordicneurolab AS · 2019
- Descendant · 3 generations on · 1 of its ownK232680 fMRI Hardware SystemNordicneurolab AS · 2023
- Descendant · 4 generations on · 0 of its ownK251937 nordicAudio (1.0)Nordicneurolab AS · 2026
- Descendant · cites it directly · 0 of its ownK093336 Integrated Stimulus Delivery System Optimum and PremiumMedical Numerics, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K092253Modification to Fmri Hardware SystemNordicneurolab · 2009 · cites it directly3descendants
- K191032fMRI Hardware SystemNordicneurolab AS · 2019 · 2 generations on2descendants
- K232680fMRI Hardware SystemNordicneurolab AS · 2023 · 3 generations on1descendant
- K251937nordicAudio (1.0)Nordicneurolab AS · 2026 · 4 generations on0descendants
- K093336Integrated Stimulus Delivery System Optimum and PremiumMedical Numerics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043290 | Mindstate Functional Data Acquisition Device, Version 1.0 | Neurognostics, Inc. | 2005 | — |
| −1 | K073099 | Fmri Hardware System | Nordicneurolab | 2007 | — |
| 0 (this device) | K080515 | Fmri Hardware System | Nordicneurolab | 2008 | — |
| +1 | K092253 | Modification to Fmri Hardware System | Nordicneurolab | 2009 | 1 |
| +2 | K191032 | fMRI Hardware System | Nordicneurolab AS | 2019 | — |
| +3 | K232680 | fMRI Hardware System | Nordicneurolab AS | 2023 | — |
| +4 | K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026 | — |
| +1 | K093336 | Integrated Stimulus Delivery System Optimum and Premium | Medical Numerics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K073099 | Fmri Hardware SystemSummary page 1…Fax: +47 55 70 70 96 E-mail: [email protected] Legally marketed Device name and 510(k) number: fMRI Hardware System. K073099 Modified Device Name fMRI Hardware System Device Common Name: Accessory to MRI System, Nuclear Magnetic R… | 2007 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2017 | Class II | Z-2103-2018 | Device Design | Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K092253 (Nordicneurolab, 2009) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K073099.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 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/K080515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080515: 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/K080515
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