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
qER-CTA (v1.0)
Qure.ai Technologies
Authorized purpose: Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.
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: Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Brain anterior circulation: internal carotid artery and M1 segment of the middle cerebral artery Input: DICOM head CTA images acquired in the acute setting from adults aged 22 and older, targeting the ICA and MCA-M1 for LVO analysis.
- Who uses it? Intended users: Neurologists, neuroradiologists, radiologists, neuro-interventional specialists, and/or other emergency department physicians
- What does the software produce? Output: A case-level passive notification flag available in a PACS or workstation for worklist prioritization, specialist notifications recommending image review, and a compressed informational mobile preview; FDA testing also reports a mean time to notification of 6.36 minutes.
- What is its most important limitation? Key limitation: Compressed mobile previews are informational and not for diagnostic use. The device does not direct attention to specific image portions, rule out LVO, or replace full patient evaluation or diagnosis. It analyzes the specified ICA and MCA-M1 territory in adults aged 22 and older and does not send proactive alerts or change worklist order.
Clinical takeaway
Clinical role: Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.
Evidence takeaway
Evidence from the reviewed source record: FDA standalone clinical testing used 584 head CTA scans, including 289 LVO-positive and 295 non-LVO scans, with ground truth from three U.S. board-certified neuroradiologists. FDA reports AUC 0.959, sensitivity 91.35% (95% CI 87.54%-94.07%), specificity 91.86% (95% CI 88.18%-94.47%), and mean time to notification 6.36 minutes (95% CI 6.06-6.66).
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
- Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.
- Intended users
- Neurologists, neuroradiologists, radiologists, neuro-interventional specialists, and/or other emergency department physicians
- Care setting and population
- Hospital networks and acute neurovascular clinical workflow
- Workflow role
- Parallel triage and notification support using a passive case-level flag for suspected LVO; the standard-of-care read remains required.
- Required input
- DICOM head CTA images acquired in the acute setting from adults aged 22 and older, targeting the ICA and MCA-M1 for LVO analysis.
- Output and human action
- A case-level passive notification flag available in a PACS or workstation for worklist prioritization, specialist notifications recommending image review, and a compressed informational mobile preview; FDA testing also reports a mean time to notification of 6.36 minutes.
- Limitations
- Compressed mobile previews are informational and not for diagnostic use. The device does not direct attention to specific image portions, rule out LVO, or replace full patient evaluation or diagnosis. It analyzes the specified ICA and MCA-M1 territory in adults aged 22 and older and does not send proactive alerts or change worklist order.
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
- For de-identified CTA scans, transmission functions in the PACS or workstation send data to qER-CTA and results return to the PACS or another specified radiology database. A client without de-identification/re-identification can use an on-premises gateway. A mobile app provides compressed previews.
- 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.
Result destination
PACS and workstation are explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for qER-CTA (v1.0); 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 standalone clinical testing used 584 head CTA scans, including 289 LVO-positive and 295 non-LVO scans, with ground truth from three U.S. board-certified neuroradiologists. FDA reports AUC 0.959, sensitivity 91.35% (95% CI 87.54%-94.07%), specificity 91.86% (95% CI 88.18%-94.47%), and mean time to notification 6.36 minutes (95% CI 6.06-6.66).
- Reported sensitivity
- 91.35% (95% CI: 87.54%, 94.07%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 91.86% (95% CI: 88.18%, 94.47%)
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.
qER-CTA (v1.0) regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K251610
- Samplen=584
- IndependenceIndependence not established
K251610
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 K251610 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 K251610. 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 K251610 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
2026-09-19Last searched
26Fields 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
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FDA K251610: qER-CTA (v1.0)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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qER-CTA (v1.0) model card (K251610)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K251610
Scope: postmarketSafety
Research history
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K251610 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
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