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 Sep 7, 2017 as substantially equivalent to K061855 (Cortechs Labs, Inc., 2006) after a 157-day review. Its family tree reaches back 1 generation to 2006. 28 later devices descend from it.
- Decided
- Sep 7, 2017
- Review
- 157 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061855 (2006). 28 later devices descend from it, 14 citing it directly.
- Root · 1 generation backK061855 NeuroquantCortechs Labs, Inc. · 2006
- This deviceK170981 NeuroQuantCortechs Labs, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK220437 Neurophet AQUANeurophet., Inc. · 2023
- Descendant · cites it directly · 3 of its ownK221738 NS-HGlioNeosoma, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK242215 Neurophet AQUA (V3.1)Neurophet., Inc. · 2024
- Descendant · cites it directly · 2 of its ownK241098 NeuroQuantCortechs Labs, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK232231 QP-Brain®Quibim S.L. · 2023
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K220437Neurophet AQUANeurophet., Inc. · 2023 · cites it directly3descendants
- K221738NS-HGlioNeosoma, Inc. · 2022 · cites it directly3descendants
- K242215Neurophet AQUA (V3.1)Neurophet., Inc. · 2024 · 2 generations on2descendants
- K241098NeuroQuantCortechs Labs, Inc. · 2024 · cites it directly2descendants
- K232231QP-Brain®Quibim S.L. · 2023 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| 0 (this device) | K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017 | — |
| +1 | K220437 | Neurophet AQUA | Neurophet., Inc. | 2023 | — |
| +1 | K221738 | NS-HGlio | Neosoma, Inc. | 2022 | — |
| +2 | K242215 | Neurophet AQUA (V3.1) | Neurophet., Inc. | 2024 | — |
| +1 | K241098 | NeuroQuant | Cortechs Labs, Inc. | 2024 | — |
| +1 | K232231 | QP-Brain® | Quibim S.L. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 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? (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 |
|---|---|---|---|
| * | K061855 | NeuroquantSummary page 4…uct Code: LLZ Classification Panel: Radiology 3. Predicate Device Device: NeuroQuant™ 510(k) Number K061855 Manufacturer CorTechs Labs, Inc Product Code: LLZ… | 2006 |
What descends from it? (28)
See all 2814 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 LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric measurements may be compared to reference percentile data.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170981: NeuroQuant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170981
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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