510(k) · Cleared
ClearedViz HDS, Viz Volume Plus, Viz ICH+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viz. Ai, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Feb 5, 2024 as substantially equivalent to K211222 (Qure.Ai Technologies, 2021) after a 182-day review. Its family tree reaches back 5 generations to 2006. 2 later devices descend from it.
- Decided
- Feb 5, 2024
- Review
- 182 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K061855 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 4 generations backK161148 icobrainIcometrix · 2016
- 3 generations backK180326 icobrainIcometrix · 2018
- 2 generations backK181939 icobrainIcometrix NV · 2018
- 1 generation backK211222 qER-QuantQure.Ai Technologies · 2021
- This deviceK232363 Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260406 Brainomix 360 HyperdensityBrainomix Limited · 2026
- Descendant · cites it directly · 0 of its ownK250354 Viz Subdural+, Viz SUBDURAL PLUSViz. Ai, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| −4 | K161148 | icobrain | Icometrix | 2016 | — |
| −3 | K180326 | icobrain | Icometrix | 2018 | — |
| −2 | K181939 | icobrain | Icometrix NV | 2018 | — |
| −1 | K211222 | qER-Quant | Qure.Ai Technologies | 2021 | — |
| 0 (this device) | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. | 2024 | — |
| +1 | K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | 2026 | — |
| +1 | K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Viz. Ai, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K211222 | qER-QuantSummary page 5…Devices Manufacturer Device Name Application No. Qure.ai technologies qER-Quant K211222 Device Description Viz HDS is a software-only device that uses a locked artificial intelligence machine learning… | 2021 |
What descends from it? (2)
2 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 18 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K260406 (Brainomix Limited, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K211222.
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. 2024, 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?
The Viz HDS device is intended for automatic labeling, visualization, and quantification of segmentable brain structures from a set of Non-Contrast CT (NCCT) head scans. The software is intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on NCCT images. Viz HDS provides volumes from NCCT scans acquired at a single time point. The Viz HDS software is indicated for use in the analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift. 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/K232363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232363: Viz HDS, Viz Volume Plus, Viz ICH+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232363
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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