# K250685: Methinks NCCT Stroke

- Pathway: 510(k) (Traditional)
- Applicant: Methinks Software, S.L
- Decided: Jun 16, 2025 after 102 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222884: Rapid NCCT Stroke, Ischemaview, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250685
Methodology: https://510kreport.com/methodology