510(k) · Cleared
ClearedMindstate Functional Data Acquisition Device (Fdad), 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 Oct 17, 2005 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 17, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK052571 Mindstate Functional Data Acquisition Device (Fdad), Version 1.0Neurognostics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK093336 Integrated Stimulus Delivery System Optimum and PremiumMedical Numerics, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K052571 | Mindstate Functional Data Acquisition Device (Fdad), Version 1.0 | Neurognostics, Inc. | 2005 | — |
| +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 |
|---|---|---|
| 2010 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093336 | Integrated Stimulus Delivery System Optimum and Premium | 2010 | 0 |
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, K093336 (Medical Numerics, Inc., 2010) has gone furthest, with 0 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 cnv1rfITr'leIt to perform (unctional MRI (fMR.I) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. [DAD presents a stimulus to the patient mid collects the patient's responses by the palieril in response to a set of stimuli creates the necessary behavioral data- the tMRI data comprised of the MRP images (in DICOM tbrmal) sent from the MR…
Read the full statement (140 words)
The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI cnv1rfITr'leIt to perform (unctional MRI (fMR.I) procedures based on Blood Oxygen Level Dependent (BOLD) contrast.
[DAD presents a stimulus to the patient mid collects the patient's responses by the palieril in response to a set of stimuli creates the necessary behavioral data- the tMRI data comprised of the MRP images (in DICOM tbrmal) sent from the MR scanner control station, and the behavioral response (binary) data arc archived to a removable media by tDAD.
The tDAD-PT ([DAD Personal 'frainer) 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 f'DAD-YI control stalion andof the response to be provided.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052571 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052571: Mindstate Functional Data Acquisition Device (Fdad), Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052571
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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