510(k) · Cleared
ClearediQ-solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sydney Neuroimaging Analysis Centre Pty, Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Dec 18, 2023 as substantially equivalent to K192130 (Icometrix NV, 2019) after a 171-day review. Its family tree reaches back 5 generations to 2006.
- Decided
- Dec 18, 2023
- Review
- 171 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K061855 (2006). No later device cites it as a predicate yet.
- 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 backK192130 IcobrainIcometrix NV · 2019
- This deviceK231929 iQ-solutionsSydney Neuroimaging Analysis Centre Pty, Ltd. · 2023
View 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 | K192130 | Icobrain | Icometrix NV | 2019 | — |
| 0 (this device) | K231929 | iQ-solutions | Sydney Neuroimaging Analysis Centre Pty, Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K192130 | IcobrainSummary page 5…H, LLZ 5.3 Predicate Device Product Name: icobrain Device Trade Name: Icobrain 510(k) Number K192130 Clearance Date: December 13, 2019 Manufacturer: icometrix NV Common Name… | 2019 |
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 17 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K192130.
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. 2023, 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?
1Q-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. 1Q-solutions™ consists of both cross-sectional and longitudinal analysis…
Read the full statement (137 words)
1Q-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans.
1Q-solutions™ consists of both cross-sectional and longitudinal analysis pipelines.
» The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point.
The longitudinal pipeline is intended to conduct volume change analysis on a single patient’s MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points.
The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.
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/K231929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231929: iQ-solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231929
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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