JLK-SDH

K243611

JLK, Inc. · cleared 2025-03-03 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
JLK-SDH is a notification-only, parallel workflow tool that is intended to assist trained radiologists to identify and communicate images of specific patients to a specialist, independent of the standard of care workflow. JLK-SDH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate user of these findings in parallel to standard of care image interpretation. JLK-SDH is a radiological computer-assisted triage and notification (CADt) software package compliant with the DICOM standard.
Algorithmartificial intelligence algorithm, convolutional neural network (CNN), AI model, machine learning
source quote (p.4)
JLK-SDH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate user of these findings in parallel to standard of care image interpretation. Utilizing an artificial intelligence algorithm, the system automatically receives and analyzes NCCT studies for image features indicating the presence of SDH and sends a notification to alert a radiologist of the case. The training dataset utilized to develop the convolutional neural network (CNN) included 29,524 non-contrast CT (NCCT) scans that had been obtained in patients with and without intracranial hemorrhage. This broad collection of both US and Out-of-US data ensures that the Al model is trained on a diverse set of cases, enhancing its applicability across different populations and clinical environments. Both the subject and predicate devices utilize artificial intelligence and machine learning (AI/ML) algorithms and mobile notification software to identify and notify specialists, respectively, of patients with the presence of suspected subdural hemorrhage (SDH) on non-contrast CT imaging of the head.
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=560 scans

endpoints: sensitivity; specificity

standards: Content of Premarket Submissions for Device Software Functions

Reported performance (4 observations)

sensitivity0.971CI 95% confidence interval (CI) of 94.4% to 99.4%
source quote (p.9)
The sensitivity was 97.1%, with a 95% confidence interval (CI) of 94.4% to 99.4%.
specificity0.974CI 95% CI of 95.8% to 99.0%
source quote (p.9)
The specificity was 97.4%, with a 95% CI of 95.8% to 99.0%.
aurocas written: “auc0.974CI 95% CI of 0.958 to 0.989
source quote (p.9)
The area under the curve (AUC) was 0.974 with a 95% CI of 0.958 to 0.989.
time_to_resultas written: “time-to-notification0.19CI ±0.05 minutes
source quote (p.12)
A secondary endpoint of time-to-notification from non-contrast CT scans to notification for SDH-positive cases was also evaluated. The JLK-SDH system for SDH-positive cases demonstrated efficient triage with a total NCCT-to-notification time ranging from an average of 11.49±3.04 seconds (0.19± 0.05 minutes), which successfully meets the target of 69.1±34.3 seconds (1.15±0.57 minutes) established by the predicate device, Viz SDH (K220439).

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K243611