510(k) · Cleared
ClearedFmri 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 Nov 20, 2007 as substantially equivalent to K043290 (Neurognostics, Inc., 2005) after an 18-day review. Its family tree reaches back 1 generation to 2005. 7 later devices descend from it.
- Decided
- Nov 20, 2007
- Review
- 18 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043290 (2005). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK043290 Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005
- This deviceK073099 Fmri Hardware SystemNordicneurolab · 2007
- Descendant · cites it directly · 5 of its ownK080515 Fmri Hardware SystemNordicneurolab · 2008 · Recalled
- Descendant · 2 generations on · 3 of its ownK092253 Modification to Fmri Hardware SystemNordicneurolab · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK191032 fMRI Hardware SystemNordicneurolab AS · 2019
- Descendant · 4 generations on · 1 of its ownK232680 fMRI Hardware SystemNordicneurolab AS · 2023
- Descendant · 5 generations on · 0 of its ownK251937 nordicAudio (1.0)Nordicneurolab AS · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080515Fmri Hardware SystemNordicneurolab · 2008 · cites it directly5descendants
- K092253Modification to Fmri Hardware SystemNordicneurolab · 2009 · 2 generations on3descendants
- K191032fMRI Hardware SystemNordicneurolab AS · 2019 · 3 generations on2descendants
- K232680fMRI Hardware SystemNordicneurolab AS · 2023 · 4 generations on1descendant
- K251937nordicAudio (1.0)Nordicneurolab AS · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043290 | Mindstate Functional Data Acquisition Device, Version 1.0 | Neurognostics, Inc. | 2005 | — |
| 0 (this device) | K073099 | Fmri Hardware System | Nordicneurolab | 2007 | — |
| +1 | K080515 | Fmri Hardware System | Nordicneurolab | 2008 | 1 |
| +2 | K092253 | Modification to Fmri Hardware System | Nordicneurolab | 2009 | 1 |
| +3 | K191032 | fMRI Hardware System | Nordicneurolab AS | 2019 | — |
| +4 | K232680 | fMRI Hardware System | Nordicneurolab AS | 2023 | — |
| +5 | K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K043290 | Mindstate Functional Data Acquisition Device, Version 1.0Summary page 3…n sequence. Statement of Substantial Equivalence: The NordicNeuroLab fMRI System is substantially equivalent to the MindState Functional Data Acquisition Device (fDAD), K043290. The two devices have the same intended use and use similar components to achieve the intended use. Summary of Testing: The Nord… | 2005 |
What descends from it? (7)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2007, 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/K073099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073099: 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/K073099
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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