Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
uAI Easy Triage ICH
Shanghai United Imaging Intelligence Co., Ltd.
Authorized purpose: Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Head/brain; intracranial hemorrhage Input: Non-enhanced head CT images in DICOM format that are compatible with prescribed acquisition protocols; the application reads and verifies DICOM compatibility before triage.
- Who uses it? Intended users: Hospital networks and trained radiologists.
- What does the software produce? Output: Suspected ICH positive or negative triage classification, active alert icon and pending-case count, patient-detail/status notifications, passive worklist icon, and an informational DICOM image preview without diagnostic markers.
- What is its most important limitation? Key limitation: The preview is informational and not for definitive diagnosis; the device does not mark or highlight a region of interest and does not alter the original image. Full-image review and standard clinical judgment remain required. The FDA packet describes no clinical study as required for the substantial-equivalence determination, while the performance section reports a retrospective validation study.
Clinical takeaway
Clinical role: Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.
Evidence takeaway
Evidence from the reviewed source record: FDA retrospective validation used 295 non-contrast head CT studies from four U.S. states, with 147 ICH-positive and 148 ICH-negative cases. Ground truth was a majority read by three U.S.-board-certified neuroradiologists. Sensitivity was 92% (95% CI 86%-96%), specificity was 95% (95% CI 90%-98%), and mean time to notification was 41.1 seconds (95% CI 40.1-42.1).
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.
- Intended users
- Hospital networks and trained radiologists.
- Care setting and population
- Hospital-network radiology worklist and triage workflow operating in parallel with standard of care.
- Workflow role
- Case-level notification and worklist prioritization using active and passive alerts, with a non-diagnostic DICOM preview for initial review.
- Required input
- Non-enhanced head CT images in DICOM format that are compatible with prescribed acquisition protocols; the application reads and verifies DICOM compatibility before triage.
- Output and human action
- Suspected ICH positive or negative triage classification, active alert icon and pending-case count, patient-detail/status notifications, passive worklist icon, and an informational DICOM image preview without diagnostic markers.
- Limitations
- The preview is informational and not for definitive diagnosis; the device does not mark or highlight a region of interest and does not alter the original image. Full-image review and standard clinical judgment remain required. The FDA packet describes no clinical study as required for the substantial-equivalence determination, while the performance section reports a retrospective validation study.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- A component of the uAI Easy Triage Platform that reads DICOM files, performs triage, and communicates findings in DICOM format with platform worklist and alert functions. Specific PACS, RIS, EHR, hosting, and local interface compatibility are not established.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for uAI Easy Triage ICH; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- FDA retrospective validation used 295 non-contrast head CT studies from four U.S. states, with 147 ICH-positive and 148 ICH-negative cases. Ground truth was a majority read by three U.S.-board-certified neuroradiologists. Sensitivity was 92% (95% CI 86%-96%), specificity was 95% (95% CI 90%-98%), and mean time to notification was 41.1 seconds (95% CI 40.1-42.1).
- Reported sensitivity
- 92% (95% CI: 86%, 96%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 95% (95% CI: 90%, 98%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
uAI Easy Triage ICH regulatory performance study summary
- DesignStand-Alone Performance
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K242292
- Samplen=295
- IndependenceIndependence not established
K242292
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K242292 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K242292. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K242292 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
24Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
-
FDA K242292: uAI Easy Triage ICH
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
uAI Easy Triage ICH model card (K242292)
Scope: intendedUsers, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K242292
Scope: postmarketSafety
Research history
-
K242292 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
FDA-cleared K252421
JLK-NCCT
JLK, Inc.
Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...
- Modality
- CT/CTA
- Anatomy
- Brain and intracranial vessels: intracranial hemorrhage and LVO involving ICA, MCA-M1, and MCA-M2
- Decision
- 2026-03-24
FDA-cleared K250694
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.
- Modality
- CT/CTA
- Anatomy
- Brain/Head
- Decision
- 2025-11-25
FDA-cleared K251983
Brainomix 360 Triage Stroke
Brainomix Limited
Triage and notification of suspected intracranial hemorrhage or anterior-circulation LVO on acute non-contrast head CT; not primary diagnosis.
- Modality
- CT/CTA
- Anatomy
- Brain/head, including intracranial ICA and M1 for LVO and intracranial hemorrhage findings
- Decision
- 2025-08-26
FDA-cleared K251590
Methinks CTA Stroke
Methinks Software S.L.
Methinks CTA Stroke analyzes acute-setting brain CT angiography in adults over 21 with suspected stroke for suspected large-vessel occlusion in the terminal ICA, MCA-M1, or MCA-M2...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-08-20