510(k) · Cleared
Clearedsyngo.CT Brain Hemorrhage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Mar 22, 2024 as substantially equivalent to K203260 (Siemens Medical Solutions USA, Inc., 2022) after a 224-day review. Its family tree reaches back 3 generations to 2018. 1 later device descends from it.
- Decided
- Mar 22, 2024
- Review
- 224 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK182177 AccipiolxMaxq-Al, Ltd. · 2018
- 1 generation backK203260 syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. · 2022
- This deviceK232431 syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK243145 syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243145syngo.CT LVO DetectionSiemens Medical Solutions USA, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K182177 | Accipiolx | Maxq-Al, Ltd. | 2018 | — |
| −1 | K203260 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2022 | — |
| 0 (this device) | K232431 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +1 | K243145 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 QAS? 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 QAS device
- #1 K203508 BriefCasescore 25.5 · 4 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 |
|---|---|---|---|
| * | K203260 | syngo.CT Brain HemorrhageSummary page 4…CFR §892.2080 Device Class: Class II Product Code: QAS 3. Predicate Device Trade Name: syngo.CT Brain Hemorrhage 510(k) Number: K203260 Clearance Date: 01/28/2022 Classification Name: Radiological Computer-Assisted Triage and Notification Software Classi… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243145 | syngo.CT LVO Detection | 2025 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243145 (Siemens Medical Solutions USA, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QAS devicesQAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QAS
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAS
101in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAS
No recall names QAS since 2007.
Adverse event reports per year · QAS
No MAUDE report names QAS since 2007.
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 | 3 | — | 0 | 0 |
| 2019 | 5 | 111 | 0 | 0 |
| 2020 | 12 | 112 | 0 | 0 |
| 2021 | 5 | 86 | 0 | 0 |
| 2022 | 15 | 116 | 0 | 0 |
| 2023 | 11 | 98 | 0 | 0 |
| 2024 | 12 | 136 | 0 | 0 |
| 2025 | 15 | 101 | 0 | 0 |
| 2026 | 11 | 104 | 0 | — |
What is it indicated for?
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage, also in the subarachnoid space, on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a standalone diagnostic device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232431: syngo.CT Brain Hemorrhage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232431
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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