510(k) · Cleared
ClearedNeurophet AQUA (V3.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurophet., Inc. · QIH Automated Radiological Image Processing Software
Cleared on Oct 25, 2024 as substantially equivalent to K220437 (Neurophet., Inc., 2023) after an 88-day review. Its family tree reaches back 3 generations to 2006. 2 later devices descend from it.
- Decided
- Oct 25, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061855 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 2 generations backK170981 NeuroQuantCortechs Labs, Inc. · 2017
- 1 generation backK220437 Neurophet AQUANeurophet., Inc. · 2023
- This deviceK242215 Neurophet AQUA (V3.1)Neurophet., Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261273 Neurophet AQUANeurophet., Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251483 SwiftSight-BrainAirs Medical, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| −2 | K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017 | — |
| −1 | K220437 | Neurophet AQUA | Neurophet., Inc. | 2023 | — |
| 0 (this device) | K242215 | Neurophet AQUA (V3.1) | Neurophet., Inc. | 2024 | — |
| +1 | K261273 | Neurophet AQUA | Neurophet., Inc. | 2026 | — |
| +1 | K251483 | SwiftSight-Brain | Airs Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K220437 | Neurophet AQUASummary page 6…sions from a set of MR images. Volumetric data may be compared to reference percentile data. 9. Predicate Device: ⚫ Primary Predicate: Neurophet AQUA v2.1 (K220437) by NEUROPHET, Inc. ⚫ Reference Device: NeuroQuant® v2.2 (K170981) by CorTechs Labs, Inc.… | 2023 |
| † | K170981 | NeuroQuant | 2017 |
What descends from it? (2)
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K261273 (Neurophet., Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data 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/K242215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242215: Neurophet AQUA (V3.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242215
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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