510(k) · Cleared
ClearedBrainomix 360 Hyperdensity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainomix Limited · QIH Automated Radiological Image Processing Software
Cleared on Jun 12, 2026 as substantially equivalent to K232363 (Viz. Ai, Inc., 2024) after a 123-day review. Its family tree reaches back 6 generations to 2006.
- Decided
- Jun 12, 2026
- Review
- 123 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K061855 (2006). No later device cites it as a predicate yet.
- Root · 6 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 5 generations backK161148 icobrainIcometrix · 2016
- 4 generations backK180326 icobrainIcometrix · 2018
- 3 generations backK181939 icobrainIcometrix NV · 2018
- 2 generations backK211222 qER-QuantQure.Ai Technologies · 2021
- 1 generation backK232363 Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc. · 2024
- This deviceK260406 Brainomix 360 HyperdensityBrainomix Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| −5 | K161148 | icobrain | Icometrix | 2016 | — |
| −4 | K180326 | icobrain | Icometrix | 2018 | — |
| −3 | K181939 | icobrain | Icometrix NV | 2018 | — |
| −2 | K211222 | qER-Quant | Qure.Ai Technologies | 2021 | — |
| −1 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. | 2024 | — |
| 0 (this device) | K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | 2026 | — |
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 |
|---|---|---|---|
| * | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+Summary page 5…Class II Regulation Name: Medical image management and processing system Product Code: QIH Submission Number: K232363 2 Device Description Brainomix 360 Hyperdensity is a software-only device that uses a locked artificial intelligence mach… | 2024 |
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 20 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K232363.
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. 2026, 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?
Brainomix 360 Hyperdensity is intended for automatic labeling, visualization, and volumetric quantification of
intracranial hyperdensities from a set of Non-Contrast CT (NCCT) head scans acquired at a single time point.
The device output should be reviewed along with patient’s original images by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260406: Brainomix 360 Hyperdensity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260406
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026