510(k) · Cleared
ClearedQP-Brain®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quibim S.L. · QIH Automated Radiological Image Processing Software
Cleared on Dec 13, 2023 as substantially equivalent to K170981 (Cortechs Labs, Inc., 2017) after a 139-day review. Its family tree reaches back 2 generations to 2006. 2 later devices descend from it.
- Decided
- Dec 13, 2023
- Review
- 139 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061855 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 1 generation backK170981 NeuroQuantCortechs Labs, Inc. · 2017
- This deviceK232231 QP-Brain®Quibim S.L. · 2023
- Descendant · cites it directly · 1 of its ownK250416 GBrain MRIGalileo Cds, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252362 GBrain MRIGalileo Cds, 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 |
|---|---|---|---|---|---|
| −2 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| −1 | K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017 | — |
| 0 (this device) | K232231 | QP-Brain® | Quibim S.L. | 2023 | — |
| +1 | K250416 | GBrain MRI | Galileo Cds, Inc. | 2025 | — |
| +2 | K252362 | GBrain MRI | Galileo Cds, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K170981 | NeuroQuantSummary page 5…Device • Manufacturer’s name: CorTechs Labs, Inc. 4690 Executive Drive, Suite 250, San Diego, CA 92121 • Device’s trade name: NeuroQuant • 510(k) number: K170981 • Product code: LLZ Reference Devices Reference Device #1: • Manufacturer’s name: Quantib B.V. Westblaak 106, 3012 KM Rott… | 2017 |
| † | K173939 | Quantib Brain | 2018 |
| † | K192531 | QyScore Software | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250416 | GBrain MRI | 2025 | 1 |
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 17 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250416 (Galileo Cds, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K170981.
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. 2023, 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?
QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application is used by clinicians with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be based solely on the results of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232231: QP-Brain®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232231
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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