510(k) · Cleared
ClearedNeuroquant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortechs Labs, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 10, 2006 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 57 later devices descend from it.
- Decided
- Aug 10, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 6 citing it directly.
- This deviceK061855 NeuroquantCortechs Labs, Inc. · 2006
- Descendant · cites it directly · 28 of its ownK170981 NeuroQuantCortechs Labs, Inc. · 2017
- Descendant · cites it directly · 22 of its ownK161148 icobrainIcometrix · 2016
- Descendant · 2 generations on · 19 of its ownK180326 icobrainIcometrix · 2018
- Descendant · 3 generations on · 18 of its ownK181939 icobrainIcometrix NV · 2018
- Descendant · 4 generations on · 13 of its ownK211222 qER-QuantQure.Ai Technologies · 2021
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K170981NeuroQuantCortechs Labs, Inc. · 2017 · cites it directly28descendants
- K161148icobrainIcometrix · 2016 · cites it directly22descendants
- K180326icobrainIcometrix · 2018 · 2 generations on19descendants
- K181939icobrainIcometrix NV · 2018 · 3 generations on18descendants
- K211222qER-QuantQure.Ai Technologies · 2021 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| +1 | K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017 | — |
| +1 | K161148 | icobrain | Icometrix | 2016 | — |
| +2 | K180326 | icobrain | Icometrix | 2018 | — |
| +3 | K181939 | icobrain | Icometrix NV | 2018 | — |
| +4 | K211222 | qER-Quant | Qure.Ai Technologies | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 7 | 0 |
| 2025 | 12 | 0 |
| 2026 | 8 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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? (57)
See all 576 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, K170981 (Cortechs Labs, Inc., 2017) has gone furthest, with 28 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
NeuroQuantTM is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061855 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061855: Neuroquant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061855
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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