510(k) · Cleared
Clearedsyngo.CT Brain Quantification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 25, 2026 as substantially equivalent to K211222 (Qure.Ai Technologies, 2021) after a 260-day review. Its family tree reaches back 5 generations to 2006.
- Decided
- Sep 25, 2026
- Review
- 260 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 backK211222 qER-QuantQure.Ai Technologies · 2021
- This deviceK260055 syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc. · 2026
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 | K211222 | qER-Quant | Qure.Ai Technologies | 2021 | — |
| 0 (this device) | K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | 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 |
|---|---|---|---|
| * | K211222 | qER-QuantSummary page 6…ode: QIH 3. Predicate Devices Predicate Device: Trade Name: qER-Quant Manufacturer: Qure.Ai Technologies 510(k) Number: K211222 Clearance Date: 07/30/2021 Regulation Description: Medical Image Management and Processing System Classification Name… | 2021 |
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 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- 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. 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?
syngo.CT Brain Quantification is a radiological post-processing application for the analysis of non-contrast head CT images. The device is intended for automatic labeling, visualization, and quantification of intracranial structures.
The software is indicated for use in the analysis of:
* Intracranial hyperdensities
* Midline Shift
The device is intended to be used in patients aged 18 years or above. No surgical signs must be present in the images.
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/K260055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260055: syngo.CT Brain Quantification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260055
Report an extraction error
Are you the manufacturer?
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