uAI Easy Triage ICH

K242292

Shanghai United Imaging Intelligence Co., Ltd. · cleared 2024-09-24 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“uAI Easy Triage ICH is a radiological computer-assisted triage and notification software intended to assist radiologists by flagging potential intracranial hemorrhage (ICH) in non-contrast head CT images. The Triage Software is a component of the uAI Easy Triage platform, a comprehensive medical imaging communication system designed to integrate and deploy specialized image processing applications.”

Algorithmartificial intelligence CNN (convolutional neural networks) and advanced image processing

source quote (p.6)

“The uAI Easy Triage ICH algorithm uses artificial intelligence CNN (convolutional neural networks) and advanced image processing to triage the non-contrast CT images for suspicious intracranial hemorrhage.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.16)

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Document issued on September 27, 2023).”

Validation studies (1)

Retrospective clinical

n=295 scans

endpoints: sensitivity; specificity; time to notification

standards: NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set, ISO 14971 Medical devices – Application of risk management to medical devices (Third Edition 2019-12), IEC 62304 Medical device software - Software life cycle processes (Edition 1.1 2015-06 CONSOLIDATED VERSION), Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Document issued on September 27, 2023)

Reported performance (3 observations)

sensitivity0.92CI 95% CI: 86%-96%

source quote (p.15)

“Comparing the uAI Easy Triage ICH software output to the ground truth, the sensitivity and specificity of uAI Easy Triage ICH are 92% (95% CI: 86%-96%) and 95% (95% CI: 90%-98%), respectively, exceeding the acceptance criteria of 80%.”

specificity0.95CI 95% CI: 90%-98%

source quote (p.15)

“Comparing the uAI Easy Triage ICH software output to the ground truth, the sensitivity and specificity of uAI Easy Triage ICH are 92% (95% CI: 86%-96%) and 95% (95% CI: 90%-98%), respectively, exceeding the acceptance criteria of 80%.”

time_to_resultas written: “Time to Notification”41.1CI (40.1, 42.1)

source quote (p.16)

“The average Time to Notification in seconds was 41.1 with a 95% confidence interval (CI) for the mean equaling (40.1, 42.1).”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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).