Radiology AI Directory

FDA-cleared profile

Rapid ASPECTS (v3)

iSchemaView, Inc.

Authorized purpose: Adjunct assessment of early ischemic brain tissue injury and extent of disease in adult ischemic-stroke diagnostic imaging workup, typically within 24 hours of last known well

Stroke and ICH triage
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: Adjunct assessment of early ischemic brain tissue injury and extent of disease in adult ischemic-stroke diagnostic imaging workup, typically within 24 hours of last known well

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Adjunct assessment of early ischemic brain tissue injury and extent of disease in adult ischemic-stroke diagnostic imaging workup, typically within 24 hours of last known well

Evidence takeaway

Evidence from the reviewed source record: The FDA packet reports standalone performance on 88 cases and reader-improvement analysis on 102 scans. Standalone percent agreement with the reference at both region and scan level was 82.8%. In the reader study, agreement with the reference increased from 82% to 84% excluding the expert, and average agreement increased from 80.4% to 83.3% with assistance. A supplemental confounder set changed 3 of 115 reads (2.6%).

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
Adjunct assessment of early ischemic brain tissue injury and extent of disease in adult ischemic-stroke diagnostic imaging workup, typically within 24 hours of last known well
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Clinicians and medical imaging professionals, including neuroradiologists and other physicians; the reader study represented neurology, radiology, emergency medicine, and neurocritical care readers
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Acute ischemic-stroke diagnostic imaging, including community hospitals and primary stroke centers and acute work in comprehensive centers as described in the FDA risk-benefit discussion
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent CADx adjunct: presents original and annotated images, atlas ROIs, and numerical scoring for clinician review and verification; it is not the primary interpretation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
NCCT brain image data from adult patients presenting for diagnostic imaging workup; Rapid uses DICOM-compatible Rapid/PACS workflow and the ASPECTS processing pipeline
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automatic ASPECTS score with identified and highlighted atlas regions, numerical scoring, and overlays for early ischemic change and prior stroke areas; the clinician may review/edit the result before sending the score, selected regions, and underlying values to PACS or a workstation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Use only for ischemic stroke following standard of care; adjunct only and not a replacement for original-image review or clinical judgment; do not use CAD output as the primary interpretation; exclude technically inadequate motion, hemorrhagic transformation or hematoma, and very thin or absent ventricles
  • 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
K232156
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain/head ASPECTS regions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-01-19
  • 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
Rapid can run within the Rapid Platform on a customer server or online virtual system, receives/processes image data through the PACS/Rapid workflow, and sends the final score and regional data to PACS or a workstation using DICOM-related interoperability
  • 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

Supported acquisition environment

Scanner manufacturers: GE

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Rapid ASPECTS (v3); 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
The FDA packet reports standalone performance on 88 cases and reader-improvement analysis on 102 scans. Standalone percent agreement with the reference at both region and scan level was 82.8%. In the reader study, agreement with the reference increased from 82% to 84% excluding the expert, and average agreement increased from 80.4% to 83.3% with assistance. A supplemental confounder set changed 3 of 115 reads (2.6%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
83.3%
  • 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
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

Rapid ASPECTS (v3) regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K232156
  • Samplen=88
  • IndependenceIndependence not established

K232156

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 K232156 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 K232156. 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
12Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 12 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 12 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 K232156: Rapid ASPECTS (v3)

    U.S. Food and Drug Administration - Published 2024-01-19 - 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. Rapid ASPECTS (v3) model card (K232156)

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

    Scope: intendedUsers, output, limitations, 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 K232156

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

    Scope: postmarketSafety

Research history

  1. K232156 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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