510(k) · Cleared
ClearedBrainomix 360 e-ASPECTS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainomix Limited · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Feb 23, 2023 as substantially equivalent to K200760 (Ischemaview, Inc., 2020) after a 268-day review. Its family tree reaches back 2 generations to 2017. 2 later devices descend from it.
- Decided
- Feb 23, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170022 (2017). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN170022 QuantXQuantitative Insights, Inc. · 2017
- 1 generation backK200760 Rapid ASPECTSIschemaview, Inc. · 2020
- This deviceK221564 Brainomix 360 e-ASPECTSBrainomix Limited · 2023
- Descendant · cites it directly · 0 of its ownK250221 StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243294 Brainomix 360 e-ASPECTSBrainomix Limited · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170022 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| −1 | K200760 | Rapid ASPECTS | Ischemaview, Inc. | 2020 | — |
| 0 (this device) | K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2023 | — |
| +1 | K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | 2025 | — |
| +1 | K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 POK? 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 POK device
- #1 K242342 Fetal EchoScanscore 16.7 · 9 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 |
|---|---|---|---|
| * | K200760 | Rapid ASPECTSSummary page 5…S is Substantially Equivalent to the following Legally Marketed device: Predicate Devices 510(k) Number Trade Name Manufacturer K200760 Rapid ASPECTS iSchemaView Inc Indications for Use Brainomix 360 e-ASPECTS is a comput… | 2020 |
What descends from it? (2)
2 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 6 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250221 (Circle Cardiovascular Imaging, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K200760.
How does its category compare?
All POK devicesPOK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · POK
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POK
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POK
No recall names POK since 2007.
Adverse event reports per year · POK
1in 2021
MAUDE reports naming product code POK, 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 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 6 | 161 | 0 | 0 |
| 2025 | 5 | 119 | 0 | 0 |
| 2026 | 5 | 155 | 0 | — |
What is it indicated for?
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The software automatically registers images and uses an Atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas…
Read the full statement (403 words)
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.
The software automatically registers images and uses an Atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) Score.
Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 6 hours from time last known well).
Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to the automated ASPECTS score and the voxels excluded from the automated ASPECTS score.
Limitations:
1. Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation.
2. Brainomix 360 e-ASPECTS has been validated in patients with known MCA or ICA occlusion prior to ASPECTS scoring.
3. Brainomix 360 e-ASPECTS is not suitable for use on brain scans displaying neurological pathologies other than acute stroke, such as tumours or abscesses, haemorrhagic transformation and hematoma.
4. Use of Brainomix 360 e-ASPECTS Module in clinical settings other than brain ischemia within 6 hours from time last known well, caused by known ICA or MCA occlusions has not been tested.
5. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21.
6. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners.
7. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
Contraindications/Exclusions/Cautions:
• Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.
• Haemorrhagic Transformation, Hematoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221564: Brainomix 360 e-ASPECTS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221564
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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