510(k) · Cleared
ClearedBrain WMH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantib B.V. · QIH Automated Radiological Image Processing Software
Cleared on Sep 25, 2025 as substantially equivalent to K213737 (Quantib B.V., 2022) after a 129-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Sep 25, 2025
- Review
- 129 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011196 (2001). No later device cites it as a predicate yet.
- Root · 7 generations backK011196 Iquantify, Version 1.0Insightful Corporation · 2001
- 6 generations backK050703 QbrainMedis Medical Imaging Systems BV · 2005
- 5 generations backK153351 Quantib Brain 1Quantib B.V. · 2016
- 4 generations backK163013 Quantib Brain 1.2Quantib B.V. · 2017
- 3 generations backK173939 Quantib BrainQuantib B.V. · 2018
- 2 generations backK182564 Quantib NDQuantib B.V. · 2018
- 1 generation backK213737 Quantib NDQuantib B.V. · 2022
- This deviceK251527 Brain WMHQuantib B.V. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011196 | Iquantify, Version 1.0 | Insightful Corporation | 2001 | — |
| −6 | K050703 | Qbrain | Medis Medical Imaging Systems BV | 2005 | — |
| −5 | K153351 | Quantib Brain 1 | Quantib B.V. | 2016 | — |
| −4 | K163013 | Quantib Brain 1.2 | Quantib B.V. | 2017 | — |
| −3 | K173939 | Quantib Brain | Quantib B.V. | 2018 | — |
| −2 | K182564 | Quantib ND | Quantib B.V. | 2018 | — |
| −1 | K213737 | Quantib ND | Quantib B.V. | 2022 | — |
| 0 (this device) | K251527 | Brain WMH | Quantib B.V. | 2025 | — |
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 |
|---|---|---|---|
| * | K213737 | Quantib NDSummary page 5…sification Names: Medical image management and processing system (892.2050) Regulation Class: II Product Code: QIH 3. Predicate Device Trade Name of Device: Quantib ND (K213737) Common or Usual Name: Medical Image Software Classification Names: Medical image management and processing system (892.2050) Reg… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
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. 2025, 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?
Intended Use Brain WMH is intended for automatic labeling, visualization, and volumetric quantification of WMH from T2w FLAIR MR images. The output consists of segmentations, visualizations and volumetric measurements of WMH. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Intended User…
Read the full statement (120 words)
Intended Use
Brain WMH is intended for automatic labeling, visualization, and volumetric quantification of WMH from T2w FLAIR MR images. The output consists of segmentations, visualizations and volumetric measurements of WMH. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting.
Intended User Population
The intended users of Brain WMH are trained medical professionals.
Intended Patient Population
Brain WMH is intended for post-processing of brain magnetic resonance imaging (MRI) data from patients 22 years of age or older, without pathologies (e.g. tumor or stroke), and treatment induced features (e.g. from prior surgery or radiation treatment), and without contrast enhancement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251527: Brain WMH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251527
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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