510(k) · Cleared
Clearedicobrain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icometrix · LLZ System, Image Processing, Radiological
Cleared on Mar 8, 2018 as substantially equivalent to K161148 (Icometrix, 2016) after a 30-day review. Its family tree reaches back 2 generations to 2006. 19 later devices descend from it.
- Decided
- Mar 8, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061855 (2006). 19 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 1 generation backK161148 icobrainIcometrix · 2016
- This deviceK180326 icobrainIcometrix · 2018
- Descendant · cites it directly · 18 of its ownK181939 icobrainIcometrix NV · 2018
- Descendant · 2 generations on · 13 of its ownK211222 qER-QuantQure.Ai Technologies · 2021
- Descendant · 3 generations on · 7 of its ownK213165 RapidIschemaview, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK233582 RapidIschemaview, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK192130 IcobrainIcometrix NV · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K181939icobrainIcometrix NV · 2018 · cites it directly18descendants
- K211222qER-QuantQure.Ai Technologies · 2021 · 2 generations on13descendants
- K213165RapidIschemaview, Inc. · 2022 · 3 generations on7descendants
- K233582RapidIschemaview, Inc. · 2024 · 4 generations on3descendants
- K192130IcobrainIcometrix NV · 2019 · 2 generations on3descendants
View 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 | K161148 | icobrain | Icometrix | 2016 | — |
| 0 (this device) | K180326 | icobrain | Icometrix | 2018 | — |
| +1 | K181939 | icobrain | Icometrix NV | 2018 | — |
| +2 | K211222 | qER-Quant | Qure.Ai Technologies | 2021 | — |
| +3 | K213165 | Rapid | Ischemaview, Inc. | 2022 | — |
| +4 | K233582 | Rapid | Ischemaview, Inc. | 2024 | — |
| +2 | K192130 | Icobrain | Icometrix NV | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K161148 | icobrainSummary page 6…cannot be compared with the results of icobrain long. This intended use of the modified device is equal to the intended use of the previously cleared predicate device [K161148]. 6 Device modifications icobrain 3.0 is an update of the icobrain 1.3 (the predicate device). The modifications… | 2016 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181939 | icobrain | 2018 | 18 |
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 2 companies; a new generation was cleared every 10.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181939 (Icometrix NV, 2018) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K161148.
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 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 images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long. icobrain cross is intended to provide…
Read the full statement (119 words)
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR 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 images.
icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.
icobrain cross is intended to provide volumes from images acquired at a single timepoint
icobrain long is intended to provide changes in volumes between two 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180326: icobrain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180326
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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