510(k) · Cleared
Clearedicobrain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icometrix NV · LLZ System, Image Processing, Radiological
Cleared on Nov 6, 2018 as substantially equivalent to K180326 (Icometrix, 2018) after a 110-day review. Its family tree reaches back 3 generations to 2006. 18 later devices descend from it.
- Decided
- Nov 6, 2018
- Review
- 110 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061855 (2006). 18 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 2 generations backK161148 icobrainIcometrix · 2016
- 1 generation backK180326 icobrainIcometrix · 2018
- This deviceK181939 icobrainIcometrix NV · 2018
- Descendant · cites it directly · 13 of its ownK211222 qER-QuantQure.Ai Technologies · 2021
- Descendant · 2 generations on · 7 of its ownK213165 RapidIschemaview, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK233582 RapidIschemaview, Inc. · 2024
- Descendant · cites it directly · 3 of its ownK192130 IcobrainIcometrix NV · 2019
- Descendant · 2 generations on · 2 of its ownK232363 Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc. · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K211222qER-QuantQure.Ai Technologies · 2021 · cites it directly13descendants
- K213165RapidIschemaview, Inc. · 2022 · 2 generations on7descendants
- K233582RapidIschemaview, Inc. · 2024 · 3 generations on3descendants
- K192130IcobrainIcometrix NV · 2019 · cites it directly3descendants
- K232363Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc. · 2024 · 2 generations on2descendants
View 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 | K161148 | icobrain | Icometrix | 2016 | — |
| −1 | K180326 | icobrain | Icometrix | 2018 | — |
| 0 (this device) | K181939 | icobrain | Icometrix NV | 2018 | — |
| +1 | K211222 | qER-Quant | Qure.Ai Technologies | 2021 | — |
| +2 | K213165 | Rapid | Ischemaview, Inc. | 2022 | — |
| +3 | K233582 | Rapid | Ischemaview, Inc. | 2024 | — |
| +1 | K192130 | Icobrain | Icometrix NV | 2019 | — |
| +2 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K180326 | icobrainSummary page 5…2/6 5.3 Predicate Device Device icobrain 510(k) Number K180326 Manufacturer icometrix NV 5.4 Intended Use icobrain is intended for automatic labeling, visualization and volu… | 2018 |
What descends from it? (18)
See all 182 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 12 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211222 (Qure.Ai Technologies, 2021) has gone furthest, with 13 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. 2018, 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?
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images. Icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. icobrain cross is intended…
Read the full statement (128 words)
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images.
Icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.
icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point.
icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints.
The results of icobrain cross cannot be compared with the results of icobrain long.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181939: icobrain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181939
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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