510(k) · Cleared
ClearedJLK-NCCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
JLK, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Mar 24, 2026 as substantially equivalent to K222884 (Ischemaview, Inc., 2023) after a 235-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Mar 24, 2026
- Review
- 235 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.
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…892.2080 Product Code(s) QAS Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # K222884 Predicate Trade Name Rapid NCCT Stroke Product Code QAS… | 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 5 companies; a new generation was cleared every 2.7 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. 2026, 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?
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…
Read the full statement (319 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252421: JLK-NCCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252421
Report an extraction error
Are you the manufacturer?
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