510(k) · Cleared
ClearedMethinks NCCT Stroke
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Methinks Software, S.L · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Jun 16, 2025 as substantially equivalent to K222884 (Ischemaview, Inc., 2023) after a 102-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Jun 16, 2025
- Review
- 102 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 2 generations backK200855 CINAAvicenna.Ai · 2020
- 1 generation backK222884 Rapid NCCT StrokeIschemaview, Inc. · 2023
- This deviceK250685 Methinks NCCT StrokeMethinks Software, S.L · 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 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 |
|---|---|---|---|
| * | K222884 | Rapid NCCT StrokeSummary page 5…DEVICE The Methinks NCCT Stroke device is claimed to be substantially equivalent to the following legally marketed predicate device: iSchemaView, Inc, Rapid NCCT Stroke, K222884. Name of the device Rapid NCCT Stroke Classification Name: Radiological computer aided triage and notification… | 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 2.3 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K222884.
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?
Methinks NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-contrast head CT (NCCT) images. The device is intended to assist hospital networks and trained physicians in workflow triage by flagging and communicating suspected positive findings of (1) Intracranial Hemorrhage (ICH) and (2) Large Vessel Occlusion (LVO) of the ICA, MCA-M1 and MCA-M2. Methinks NCCT Stroke uses an…
Read the full statement (302 words)
Methinks NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-contrast head CT (NCCT) images. The device is intended to assist hospital networks and trained physicians in workflow triage by flagging and communicating suspected positive findings of (1) Intracranial Hemorrhage (ICH) and (2) Large Vessel Occlusion (LVO) of the ICA, MCA-M1 and MCA-M2.
Methinks NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with suspected (1) ICH and (2) LVO in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS and/or notifications. Notifications include 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 Methinks NCCT 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. Methinks NCCT Stroke is for adults only.
Cautions:
- All patients should get adequate care for their symptoms including CTA and/or other appropriate care per the standard clinical practice, irrespective of the device output.
- The device is not intended to be a rule-out device and for cases that have been processed by the device without notification for "LVO Suspected" should not be viewed as indicating that LVO is excluded. All cases should undergo CTA, per the standard stroke workup.
Limitations
- The device does not replace the need for CTA in ischemic stroke workup, it provides workflow prioritization and notification only.
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/K250685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250685: Methinks NCCT Stroke.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250685
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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