Radiology AI Directory

FDA-cleared profile

StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging Inc.

Authorized purpose: ASPECTS scoring and highlighted-region/voxel visualization to assist assessment of ischemic brain injury in known MCA/ICA occlusion within 12 hours from last known well.

CT/CTA workflow
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: ASPECTS scoring and highlighted-region/voxel visualization to assist assessment of ischemic brain injury in known MCA/ICA occlusion within 12 hours from last known well.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: ASPECTS scoring and highlighted-region/voxel visualization to assist assessment of ischemic brain injury in known MCA/ICA occlusion within 12 hours from last known well.

Evidence takeaway

Evidence from the reviewed source record: FDA standalone validation used 200 NCCT scans from acute ischemic stroke patients with confirmed ICA/MCA occlusion. Region-level clustered ROC analysis reported AUC-ROC 90.9% (95% CI 88.7%-93.1%), accuracy 90.6% (95% CI 89.7%-91.5%), sensitivity 70.6% (95% CI 69.2%-72.1%), and specificity 93.9% (95% CI 93.2%-94.7%). A separate 100-scan MRMC reader study with eight readers reported aided versus unaided AUC 74.3% versus 68.6%, sensitivity 51.0% versus 41.3%, specificity 97.5% versus 95.9%, accuracy 92.0% versus 89.5%, and Fleiss kappa 60.8% versus 32.3%; VCTA concordance was 97.0%.

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
ASPECTS scoring and highlighted-region/voxel visualization to assist assessment of ischemic brain injury in known MCA/ICA occlusion within 12 hours from last known well.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Clinicians, with standard-of-care radiologist review; the physician confirms the MCA/ICA occlusion and reviews, verifies, or modifies the result.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Diagnostic imaging workup for acute ischemic stroke with known MCA or ICA occlusion
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
CADx decision support in parallel with standard-of-care interpretation; automated ASPECTS results are gated by clinician confirmation and remain editable/verified before archiving or PACS transfer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM non-contrast head CT from patients with known MCA or ICA occlusion, acute ischemic stroke workup within 12 hours from last known well, and age over 21; users must confirm the occlusion before accessing ASPECTS results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automated ASPECTS score; highlighted affected ASPECTS regions; affected side; voxel-wise VCTA heatmap; original and annotated images; and a user-verified or modified result summary that can be sent to PACS via DICOM.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not intended for primary CT interpretation. It is validated for known MCA/ICA occlusion and brain ischemia within 12 hours from last known well in patients over 21. It is contraindicated for other neurological pathologies such as tumors, abscesses, hemorrhagic transformation, or hematoma; excessive motion can make scans technically inadequate.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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.

FDA submission
K250221
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain ASPECTS regions in patients with known MCA or ICA occlusion
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-07-01
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Connects with DICOM-compliant devices, processes images using preconfigured DICOM routing, and sends results/images to PACS via DICOM for viewing on a PACS workstation, StrokeSENS UI, or another DICOM-compatible viewer. Results are clinician-verifiable and editable.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Result destination

PACS is explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for StrokeSENS ASPECTS Software Application; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

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 validation used 200 NCCT scans from acute ischemic stroke patients with confirmed ICA/MCA occlusion. Region-level clustered ROC analysis reported AUC-ROC 90.9% (95% CI 88.7%-93.1%), accuracy 90.6% (95% CI 89.7%-91.5%), sensitivity 70.6% (95% CI 69.2%-72.1%), and specificity 93.9% (95% CI 93.2%-94.7%). A separate 100-scan MRMC reader study with eight readers reported aided versus unaided AUC 74.3% versus 68.6%, sensitivity 51.0% versus 41.3%, specificity 97.5% versus 95.9%, accuracy 92.0% versus 89.5%, and Fleiss kappa 60.8% versus 32.3%; VCTA concordance was 97.0%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
70.6% (95% CI: 69.2%, 72.1%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
93.9% (95% CI: 93.2%, 94.7%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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.

StrokeSENS ASPECTS Software Application regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K250221
  • Samplen=200
  • IndependenceIndependence not established

K250221

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K250221 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K250221. 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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

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
25Fields 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

  1. FDA K250221: StrokeSENS ASPECTS Software Application

    U.S. Food and Drug Administration - Published 2025-07-01 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. StrokeSENS ASPECTS Software Application model card (K250221)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K250221

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K250221 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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