510(k) · Cleared
ClearedViz Subdural+, Viz SUBDURAL PLUS
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 Jun 10, 2025 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 10, 2025
- 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 deviceK250354 Viz Subdural+, Viz SUBDURAL PLUSViz. Ai, Inc. · 2025
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) | K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Viz. Ai, Inc. | 2025 | — |
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…e Device(s) Manufacturer Device Name Application No. Viz.ai, Inc. Viz HDS K232363 Device Description Viz Subdural+ is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) a… | 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 19 years and passes through 5 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. 2025, 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 Subdural+ (Subdural Plus) device is intended for automatic labeling, visualization and quantification of collections in the subdural space from a set of Non-Contrast Head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of collections in the subdural space identified on NCCT images. Viz Subdural+ provides volumes from NCCT images acquired at a single time point.…
Read the full statement (117 words)
The Viz Subdural+ (Subdural Plus) device is intended for automatic labeling, visualization and quantification of collections in the subdural space from a set of Non-Contrast Head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of collections in the subdural space identified on NCCT images. Viz Subdural+ provides volumes from NCCT images acquired at a single time point.
The Viz Subdural+ software is intended for labeling subdural collections and reporting the grayscale value of the collection, widest width of the subdural collection, and midline shift. The device output should be reviewed along with the patient's original images by a physician qualified to interpret brain CT images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250354: Viz Subdural+, Viz SUBDURAL PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250354
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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