510(k) · Cleared
ClearedBrainomix 360 Triage Stroke
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainomix Limited · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Aug 26, 2025 as substantially equivalent to K232496 (Brainomix Limited, 2023) after a 60-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Aug 26, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 4 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 3 generations backK200855 CINAAvicenna.Ai · 2020
- 2 generations backK222884 Rapid NCCT StrokeIschemaview, Inc. · 2023
- 1 generation backK232496 Brainomix 360 Triage StrokeBrainomix Limited · 2023
- This deviceK251983 Brainomix 360 Triage StrokeBrainomix Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −4 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −3 | K200855 | CINA | Avicenna.Ai | 2020 | — |
| −2 | K222884 | Rapid NCCT Stroke | Ischemaview, Inc. | 2023 | — |
| −1 | K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | 2023 | — |
| 0 (this device) | K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | 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 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 |
|---|---|---|---|
| * | K232496 | Brainomix 360 Triage StrokeSummary page 7…II Regulation Name: Radiological computer-assisted triage and notification software Product Code: QAS Submission Number: K232496 2 Device Description Brainomix 360 Triage Stroke (also referred to as Triage Stroke in this submission) is a radiologica… | 2023 |
| † | K231195 | Brainomix 360 Triage ICH | 2023 |
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 7 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
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. 2025, 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?
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH). Specifically, the device is intended to be…
Read the full statement (481 words)
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect symmetrical bilateral MCA occlusions.
Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification.
The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
Cautions:
* All patients should get adequate care for their symptoms, including angiography and/or other appropriate care per the standard clinical practice, irrespective of the output of Brainomix 360 Triage Stroke.
* Brainomix 360 Triage Stroke is not intended to be a rule-out device and for cases that have been processed by the device without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo angiography, per the standard stroke workup.
Limitations:
1. Brainomix 360 Triage Stroke is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
2. Brainomix 360 Triage Stroke does not replace the need for angiography in ischemic stroke workup - it provides workflow prioritization and notification only.
3. Brainomix 360 Triage Stroke has been validated and is intended to be used on Siemens, GE and Philips scanners.
4. Brainomix 360 Triage Stroke is not intended to be used on patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of stroke.
5. Brainomix 360 Triage Stroke is not intended to detect symmetrical bilateral MCA occlusions.
Contraindications:
Brainomix 360 Triage Stroke is not suitable for use with scan data containing image features associated with:
* tumours or abscesses
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/K251983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251983: Brainomix 360 Triage Stroke.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251983
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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