510(k) · Cleared
ClearedqER-Quant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qure.Ai Technologies · QIH Automated Radiological Image Processing Software
Cleared on Jul 30, 2021 as substantially equivalent to K181939 (Icometrix NV, 2018) after a 98-day review. Its family tree reaches back 4 generations to 2006. 13 later devices descend from it.
- Decided
- Jul 30, 2021
- Review
- 98 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K061855 (2006). 13 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
- 3 generations backK161148 icobrainIcometrix · 2016
- 2 generations backK180326 icobrainIcometrix · 2018
- 1 generation backK181939 icobrainIcometrix NV · 2018
- This deviceK211222 qER-QuantQure.Ai Technologies · 2021
- Descendant · cites it directly · 7 of its ownK213165 RapidIschemaview, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK233582 RapidIschemaview, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK232363 Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK243350 Rapid Neuro3DIschemaview, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK233512 Rapid (6.0)Ischemaview, Inc. · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K213165RapidIschemaview, Inc. · 2022 · cites it directly7descendants
- K233582RapidIschemaview, Inc. · 2024 · 2 generations on3descendants
- K232363Viz HDS, Viz Volume Plus, Viz ICH+Viz. Ai, Inc. · 2024 · cites it directly2descendants
- K243350Rapid Neuro3DIschemaview, Inc. · 2025 · 3 generations on1descendant
- K233512Rapid (6.0)Ischemaview, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K061855 | Neuroquant | Cortechs Labs, Inc. | 2006 | — |
| −3 | K161148 | icobrain | Icometrix | 2016 | — |
| −2 | K180326 | icobrain | Icometrix | 2018 | — |
| −1 | K181939 | icobrain | Icometrix NV | 2018 | — |
| 0 (this device) | K211222 | qER-Quant | Qure.Ai Technologies | 2021 | — |
| +1 | K213165 | Rapid | Ischemaview, Inc. | 2022 | — |
| +2 | K233582 | Rapid | Ischemaview, Inc. | 2024 | — |
| +1 | K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. | 2024 | — |
| +3 | K243350 | Rapid Neuro3D | Ischemaview, Inc. | 2025 | — |
| +2 | K233512 | Rapid (6.0) | Ischemaview, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 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 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 |
|---|---|---|---|
| * | K181939 | icobrainSummary page 4…92.2050 Product Code: QIH 1.3 Predicate Device Name of Device: Icobrain Manufacturer: Icometrix NV 510(k) Number: K181939 Intended Use / Indications for Use: The qER-Quant device is intended for automatic labeling, visualization and quantificati… | 2018 |
What descends from it? (13)
See all 134 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 15 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K213165 (Ischemaview, Inc., 2022) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K181939.
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. 2021, 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 qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures 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 segmentable brain structures identified on NCCT images. qER-Quant provides volumes from NCCT images acquired at a single time point and provides a table with…
Read the full statement (115 words)
The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures 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 segmentable brain structures identified on NCCT images.
qER-Quant provides volumes from NCCT images acquired at a single time point and provides a table with comparative analysis for two or more images that were acquired on the same scanner with the same image acquisition protocol for the same individual at multiple time points.
The qER-Quant software is indicated for use in the analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift.
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/K211222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211222: qER-Quant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211222
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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