510(k) · Cleared
ClearedcNeuro cMRI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Combinostics OY · LLZ System, Image Processing, Radiological
Cleared on Jan 8, 2018 as substantially equivalent to K061855 (Cortechs Labs, Inc., 2006) and 1 other predicate after a 248-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Jan 8, 2018
- Review
- 248 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K061855 (2006). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K231398VUNO Med-DeepBrainVuno, Inc. · 2023 · cites it directly0descendants
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) | K171328 | cNeuro cMRI | Combinostics OY | 2018 | — |
| +1 | K231398 | VUNO Med-DeepBrain | Vuno, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K061855 | NeuroquantSummary page 5…Page 1 of 6 5.3 Predicate Device Primary predicate device Device NeuroQuant 510(k) # K061855 Manufacturer CorTechs Labs, Inc. 4690 Executive Drive, Suite 250 San Diego, CA 92… | 2006 |
| * | K161148 | icobrainSummary page 5…rive, Suite 250 San Diego, CA 92121 USA Secondary predicate device Device icobrain 510(k) # K161148 Manufacturer Icometrix, Kolonel Begaultlaan 1b / 12 3012 Leuven, Belgium 5.4… | 2016 |
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 |
|---|---|---|---|
| K231398 | VUNO Med-DeepBrain | 2023 | 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 12 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231398 (Vuno, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K061855.
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?
cNeuro cMRI is intended for automatic labeling, quantification and visualization of segmentable brain structures from a set of MR images. The software is intended to automate the current manual process of identifying, labeling and quantifying the segmentable brain structures identified on MR images.
The intended user profile covers medical professionals who work with medical imaging. The intended operational environment is an office-like environment with a computer.
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/K171328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171328: cNeuro cMRI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171328
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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