510(k) · Cleared
ClearedMindstate Functional Data Acquisition Device, Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurognostics, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 28, 2005 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Jan 28, 2005
- Review
- 60 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK043290 Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK073099 Fmri Hardware SystemNordicneurolab · 2007
- Descendant · 2 generations on · 5 of its ownK080515 Fmri Hardware SystemNordicneurolab · 2008 · Recalled
- Descendant · 3 generations on · 3 of its ownK092253 Modification to Fmri Hardware SystemNordicneurolab · 2009 · Recalled
- Descendant · 4 generations on · 2 of its ownK191032 fMRI Hardware SystemNordicneurolab AS · 2019
- Descendant · cites it directly · 2 of its ownK061255 Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc. · 2006
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K073099Fmri Hardware SystemNordicneurolab · 2007 · cites it directly7descendants
- K080515Fmri Hardware SystemNordicneurolab · 2008 · 2 generations on5descendants
- K092253Modification to Fmri Hardware SystemNordicneurolab · 2009 · 3 generations on3descendants
- K191032fMRI Hardware SystemNordicneurolab AS · 2019 · 4 generations on2descendants
- K061255Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc. · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043290 | Mindstate Functional Data Acquisition Device, Version 1.0 | Neurognostics, Inc. | 2005 | — |
| +1 | K073099 | Fmri Hardware System | Nordicneurolab | 2007 | — |
| +2 | K080515 | Fmri Hardware System | Nordicneurolab | 2008 | 1 |
| +3 | K092253 | Modification to Fmri Hardware System | Nordicneurolab | 2009 | 1 |
| +4 | K191032 | fMRI Hardware System | Nordicneurolab AS | 2019 | — |
| +1 | K061255 | Brainacquirerx / Brainprocessrx Data Suite Version 1.0 | Kyron Clinical Imaging, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 112 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?
- Of its descendants, K073099 (Nordicneurolab, 2007) has gone furthest, with 7 descendants of its own.
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.
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 MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary…
Read the full statement (171 words)
The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast.
fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD.
The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043290: Mindstate Functional Data Acquisition Device, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043290
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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