Heuron ICH

K233247

Heuron Co., Ltd. · cleared 2024-05-15 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Heuron ICH is radiological computer-aided triage and notification software designed for the analysis of non-contrast head CT images in adults or transitional adolescents aged 18 and older.”
Algorithmartificial intelligence algorithm using deep learning (DL) technique of a convolutional neural network (CNN)
source quote (p.4)
“The Heuron ICH is an artificial intelligence-based solution that analyzes non-contrast CT images and provides a notification of suspected positive cases of intracranial hemorrhage (ICH) for prioritization of review. Heuron ICH uses deep learning (DL) technique of a convolutional neural network (CNN).”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.4)
“Heuron ICH registers with the hospital's Picture Archiving and Communication System (PACS) using IP, Port, AE title, and TLS authentication details. It automatically receives Non-Contrast Computed Tomography (NCCT) images in DICOM format from PACS. Upon connection request from PACS to Heuron ICH, the system verifies the IP, Port, AE title, and TLS authentication information before accepting the image transmission.”

Validation studies (1)

Retrospective clinical

n=600 images · 3 site(s)

endpoints: sensitivity; specificity; area under the receiver operating curve (AUC); time-to-notification

Reported performance (6 observations)

sensitivity86.3CI 81.9-90.3
source quote (p.7)
“Sensitivity of Heuron ICH was 86.3% (95% CI: 81.9-90.3)”
specificity87.6CI 83.9-91.0
source quote (p.7)
“specificity was 87.6% (95% CI: 83.9-91.0)”
aurocas written: “auc”0.945
source quote (p.8)
“The AUC was 0.945 when compared with the consensus diagnosis from radiologists.”
npvas written: “NPV”88.1
source quote (p.7)
“NPV was 88.1%”
ppvas written: “PPV”85.6
source quote (p.7)
“PPV was 85.6%”
time_to_resultas written: “time-to-notification”60.3CI ±39.3 seconds (range 9-161 seconds)
source quote (p.8)
“The time-to-notification, 60.3 seconds±39.3 seconds (range 9-161 seconds), was similar to other cleared devices.”

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/K233247