510(k) · Cleared
ClearedQuantib ND
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantib B.V. · LLZ System, Image Processing, Radiological
Cleared on Jan 14, 2022 as substantially equivalent to K182564 (Quantib B.V., 2018) after a 46-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Jan 14, 2022
- Review
- 46 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011196 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK011196 Iquantify, Version 1.0Insightful Corporation · 2001
- 5 generations backK050703 QbrainMedis Medical Imaging Systems BV · 2005
- 4 generations backK153351 Quantib Brain 1Quantib B.V. · 2016
- 3 generations backK163013 Quantib Brain 1.2Quantib B.V. · 2017
- 2 generations backK173939 Quantib BrainQuantib B.V. · 2018
- 1 generation backK182564 Quantib NDQuantib B.V. · 2018
- This deviceK213737 Quantib NDQuantib B.V. · 2022
- Descendant · cites it directly · 0 of its ownK251527 Brain WMHQuantib B.V. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251527Brain WMHQuantib B.V. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011196 | Iquantify, Version 1.0 | Insightful Corporation | 2001 | — |
| −5 | K050703 | Qbrain | Medis Medical Imaging Systems BV | 2005 | — |
| −4 | K153351 | Quantib Brain 1 | Quantib B.V. | 2016 | — |
| −3 | K163013 | Quantib Brain 1.2 | Quantib B.V. | 2017 | — |
| −2 | K173939 | Quantib Brain | Quantib B.V. | 2018 | — |
| −1 | K182564 | Quantib ND | Quantib B.V. | 2018 | — |
| 0 (this device) | K213737 | Quantib ND | Quantib B.V. | 2022 | — |
| +1 | K251527 | Brain WMH | Quantib B.V. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K182564 | Quantib NDSummary page 4…ment and processing system (former Picture archiving and communication system) 3 PREDICATE DEVICE Device: Quantib ND 1.5 Manufacturer: Quantib B.V. 510(k) Reg. No: K182564 This predicate has not been subject to a design-related recall. Classification Name: System, image processing, radiology (892.205… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251527 | Brain WMH | 2025 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K251527 (Quantib B.V., 2025) has gone furthest, with 0 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. 2022, 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?
Quantib ND is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib ND output consists of segmentations, visualizations and volumetric measurements of brain structures and white matter hyperintensities. Volumetric measurements may be compared to reference centile data. 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.
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/K213737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213737: Quantib ND.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213737
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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