# K252421: JLK-NCCT

- Pathway: 510(k) (Traditional)
- Applicant: JLK, Inc.
- Decided: Mar 24, 2026 after 235 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
JLK-NCCT is a radiological computer-aided triage and notification software designed for analyzing non-contrast head CT (NCCT) images. The software assists hospital networks and trained clinicians by flagging and communicating them of findings suggestive of (1) Intracranial Hemorrhage (ICH) and (2) large vessel occlusion (LVO) involving the internal carotid artery (ICA), middle cerebral artery M1 (MCA-M1) and middle cerebral artery M2 (MCA-M2) on NCCT images. JLK-NCCT employs an artificial intelligence (AI) algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on an on-premises or cloud-based JLK server. This occurs in parallel with the ongoing standard of care image interpretation. Users receive notifications for cases with suspected ICH and LVO findings via mobile devices. Notifications include compressed preview images for informational purposes only and not intended for diagnostic use beyond notification. The device does not modify the original medical image, and is not intended to be used as a primary diagnostic device. The results of JLK-NCCT are intended to be used in conjunction with other patient information and professional judgment to assist with triage and prioritization of medical images. Clinicians who receive notifications are responsible for reviewing full images per the standard of care. JLK-NCCT is intended for adults use only. Limitations and warnings: • All patients should receive appropriate care, including a CT angiography (CTA) and/or relevant treatments as part of the standard stroke workup. The device is not intended to rule out any medical conditions, therefore, cases without a “Suspected ICH” or "Suspected LVO" notification should not be assumed to exclude ICH or LVO. All cases should undergo a CTA as part of the standard stroke workup. • The device does not replace the need for CTA or MRA in ischemic stroke workup, it provides workflow prioritization and notification only. Contraindications/Exclusions: • Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. • Hemorrhagic Transformation • Very thin or no Ventricles

Source page: https://510kreport.com/device/K252421
Methodology: https://510kreport.com/methodology