Radiology AI Directory

FDA-cleared profile

Rapid LVO

iSchemaView Inc.

Authorized purpose: Notification-only triage of adult head CTA for suspected large-vessel occlusion; results do not replace diagnostic interpretation.

Acute triage and notification
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: Notification-only triage of adult head CTA for suspected large-vessel occlusion; results do not replace diagnostic interpretation.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Notification-only triage of adult head CTA for suspected large-vessel occlusion; results do not replace diagnostic interpretation.

Evidence takeaway

Evidence from the reviewed source record: Standalone performance testing reported sensitivity 0.970 (95% CI: 0.933, 0.987), specificity 0.956 (95% CI: 0.919, 0.977), and ROC AUC 0.99 (95% CI: 0.972, 0.995). Time to notification was 2.86 minutes (95% CI: 2.79, 2.92).

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
Notification-only triage of adult head CTA for suspected large-vessel occlusion; results do not replace diagnostic interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Hospital networks and trained radiologists; notified clinicians review full images per the standard of care.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication names hospital networks, trained radiologists, and notified clinicians.

Care setting and population
Adult patients; the institutional care setting requires local confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Workflow role
Triage or notification support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
DICOM-compliant medical image data from CTA scanners through the Rapid Platform interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description states the DICOM-compliant CTA-scanner input path.

Output and human action
Notifications for suspected LVO findings on a server or standalone desktop application, including compressed preview images for informational triage only.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication describes notifications and compressed preview images; it does not support the dossier's generic qualified-user output wording.

Limitations
Compressed preview images are informational only and not for diagnostic use beyond notification; the device does not alter the original medical image and is not intended to be used as a diagnostic device. Notified clinicians must view non-compressed images on a diagnostic viewer and perform appropriate patient evaluation before care-related decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

These are the exact notification, diagnostic-use, image-integrity, and clinician-review boundaries in the packet.

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
K200941
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The subject-device comparison identifies the imaging type as CT Angiography; the packet does not establish the broader CT/CTA value. Controlled directory display reconciled from exact FDA wording: CT angiography (CTA). -> CT/CTA.

Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication repeatedly specifies CTA head images; Brain is not the packet's wording for this field. Controlled directory display reconciled from exact FDA wording: Head. -> Brain.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-07-09
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

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.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Rapid LVO; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท 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
Standalone performance testing reported sensitivity 0.970 (95% CI: 0.933, 0.987), specificity 0.956 (95% CI: 0.919, 0.977), and ROC AUC 0.99 (95% CI: 0.972, 0.995). Time to notification was 2.86 minutes (95% CI: 2.79, 2.92).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact packet reports these performance values and notification time; the current 95%/95% wording is not retained.

Reported sensitivity
95%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

Reported specificity
95%
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-13

Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

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 K200941 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 K200941. 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
24Fields reviewed
10Source classes checked
4Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 4 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 4 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, fda decision summary packet, 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 K200941: Rapid LVO

    U.S. Food and Drug Administration - Published 2020-07-09 - Accessed 2026-09-19

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Rapid LVO 1.0 model card (K200941)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

  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 K200941

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

    Scope: postmarketSafety

Research history

  1. K200941 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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