Regulatory evidence record · JLK
JLK-NCCT
AI triage and notification from non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion involving the ICA, M1, or M2.
Original dossier: FDA 510(k) K252421 · Mar 24, 2026
Anonymous editorial source review; independent professional peer review is not claimed. Page updates do not reset evidence dates.
What the cited dossier supports
Independent LVO testing on 288 cases reported 78.5% sensitivity, 90.3% specificity, AUC 0.880, and mean notification time of 1.67 minutes.
Clinical boundary
Notification only: it is not a primary diagnostic tool, a negative result does not exclude disease, and CTA or MRA remains necessary for LVO evaluation.
Inclusion is not endorsement; clearance does not establish superior clinical outcomes.
Sources and check history
Sources checked Sep 6, 2026; this is the evidence-search date, not the page-update date.
Source check · Sep 6, 2026
The cited clearance and LVO values were confirmed. Labeling is adult-only. The 288-case study comprised 144 LVO-positive and 144 LVO-negative cases and evaluated LVO, not the ICH model. Notification time is not treatment-time or disability benefit; a negative notification cannot rule out ICH or LVO.
FDA database record K252421 · Decision Mar 24, 2026.
Source locations: FDA PDF pp. 4, 6, 8–9 (summary pp. 2–5).
No matching recall was returned by the identifier query. Recall queries used the listed 510(k) identifiers and product/manufacturer names. The retrieved openFDA recall dataset was last updated September 3, 2026. A missing match does not establish that a device is free of recalls, adverse events, or risk; reporting and indexing can lag.
No product-matched patient-outcome study published August 17–September 6, 2026 was verified in this targeted search. This is a search result, not proof that no new evidence exists. Older or differently named systems and company announcements were not treated as evidence of benefit for the listed version.
Targeted check of FDA decision records, cited summary sections, device-linked recall records, and indexed clinical literature. This is not a systematic review or continuous safety surveillance. Next planned safety scan: Oct 6, 2026. This check does not reset the original summary-review date.
Original FDA decision and summary (PDF)
Original summary reviewed Aug 17, 2026 · Next scheduled full regulatory review Nov 17, 2026.
Index inclusion and evidence methodology
Editorial responsibility: Neurosurgery.ai (anonymous site-name attribution). Editorial policy.