510(k) · Cleared
ClearedStrokeSENS ASPECTS Software Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circle Cardiovascular Imaging, Inc. · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Jul 1, 2025 as substantially equivalent to K221564 (Brainomix Limited, 2023) after a 158-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- Jul 1, 2025
- Review
- 158 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170022 (2017). No later device cites it as a predicate yet.
- Root · 3 generations backDEN170022 QuantXQuantitative Insights, Inc. · 2017
- 2 generations backK200760 Rapid ASPECTSIschemaview, Inc. · 2020
- 1 generation backK221564 Brainomix 360 e-ASPECTSBrainomix Limited · 2023
- This deviceK250221 StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K221564 | Brainomix 360 e-ASPECTSSummary page 6…Regulation Number: 21 CFR 892.2060 III. PREDICATE DEVICE The predicate device is Brainomix 360 e-ASPECTS manufactured by Brainomix Limited and cleared under K221564. The predicate device has not been subject to a design-related recall. Circle Cardiovascular Imaging Inc. Non-… | 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 8 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K221564.
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. 2025, 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?
StrokeSENS 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. StrokeSENS ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined…
Read the full statement (346 words)
StrokeSENS 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. StrokeSENS 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 ASPECT (Alberta Stroke Program Early CT) Score.
StrokeSENS 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. StrokeSENS ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 12 hours from time last known well).
StrokeSENS 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. StrokeSENS ASPECTS presents the original and annotated images for concurrent reads. StrokeSENS ASPECTS additionally provides a visualization of the voxels contributing to the automated ASPECTS score.
Limitations:
1. StrokeSENS ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation.
2. StrokeSENS ASPECTS has been validated in patients with known MCA or ICA occlusion prior to ASPECTS scoring.
3. Use of StrokeSENS ASPECTS in clinical settings other than brain ischemia within 12 hours from time last known well, caused by known ICA or MCA occlusions, has not been tested.
4. StrokeSENS ASPECTS has only been validated and is intended to be used in patient populations aged over 21.
Contraindications:
* StrokeSENS ASPECTS is contraindicated for use on brain scans displaying neurological pathologies other than acute ischemic stroke, such as tumors or abscesses, hemorrhagic transformation, and hematoma.
Cautions:
* Patient Motion: Excessive patient motion leading to artifacts that make the scan technically inadequate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250221: StrokeSENS ASPECTS Software Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250221
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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