JLK-ICH

K243363

JLK, Inc. · cleared 2025-01-03 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“JLK-ICH is a radiological computer-aided triage and notification software indicated for use in the analysis of non-contrast CT images.”
Algorithmartificial intelligence algorithm
source quote (p.4)
“JLK-ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of pre-specified clinical conditions and promptly notifies the appropriate medical specialists of these findings in parallel with the standard of care image interpretation. ... The AI/ML-based algorithm is designed to analyze NCCT of the head scans forwarded from CT scanners to the JLK servers.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=376 scans

endpoints: sensitivity; specificity; time-to-notification

standards: FDA's Guidance for Industry and FDA staff, "Content of Premarket Submissions for Device Software Functions,” June 14, 2023

Reported performance (4 observations)

sensitivity0.973CI 94.8% to 99.5%
source quote (p.9)
“Specifically, the sensitivity was 97.3% with a 95% confidence interval (CI) of 94.8% to 99.5%.”
specificity0.979CI 95% CI of 95.5% to 99.5%
source quote (p.9)
“The specificity was 97.9% with a 95% CI of 95.5% to 99.5%.”
aurocas written: “auc”0.978CI 0.959 to 0.992
source quote (p.9)
“The area under the curve (AUC) was 0.978 with a 95% CI of 0.959 to 0.992.”
time_to_resultas written: “NCCT-to-notification time”0.19CI 0.186-0.197
source quote (p.7)
“The average total NCCT-to-notification time for the JLK-ICH system is 0.19 ± 0.04 minutes.”

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243363