Radiology AI Directory

FDA-cleared profile

Rapid ASPECTS

iSchemaView Inc.

Authorized purpose: Adjunct evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours

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 evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Adjunct evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours

Evidence takeaway

Evidence from the reviewed source record: Concurrent-read crossover study used 50 cases with 10 regions scored independently, truthing by three experts, and eight readers. Readers agreed with the expert consensus on average 0.425 more regions per scan with Rapid ASPECTS (95% CI 0.11-0.74, p<0.0001); non-neuroradiologist agreement increased from 73.6% to 79.8%.

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 evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Physicians and clinicians, with the FDA comparison identifying neuroradiologists/clinicians and the reader study including neurologists, radiologists, emergency-medicine, and neurocritical-care specialists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Acute stroke workup in community hospitals, primary stroke centers, or comprehensive centers as described in the FDA risk-benefit discussion
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent CADx adjunct in parallel with standard of care; the physician reviews and verifies the atlas overlay and score before PACS submission
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
NCCT brain image data from patients with known MCA or ICA occlusion before ASPECT scoring; the FDA packet states validation/intended use on GE Lightspeed VCT scanners
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automatic ASPECTS score, identified/highlighted ASPECTS regions, regional voxel values, old-stroke and early-ischemic-change labels, and an editable atlas display sent to PACS or a workstation
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not for primary CT interpretation; validated for known MCA or ICA occlusion and early brain ischemia within 6 hours; use outside that setting was not tested; intended for GE Lightspeed VCT; exclude excessive 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
K200760
  • 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
2020-06-26
  • 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 Platform processes image data through PACS, notifies the physician when the score is available, permits review/editing, and sends the final score, selected regions, and values to PACS for the permanent record; DICOM compliance is stated
  • 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.

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; 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
Concurrent-read crossover study used 50 cases with 10 regions scored independently, truthing by three experts, and eight readers. Readers agreed with the expert consensus on average 0.425 more regions per scan with Rapid ASPECTS (95% CI 0.11-0.74, p<0.0001); non-neuroradiologist agreement increased from 73.6% to 79.8%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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 regulatory performance study summary

  • DesignReader Study
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K200760
  • IndependenceIndependence not established

K200760

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 K200760 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 K200760. 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
22Fields 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 K200760: Rapid ASPECTS

    U.S. Food and Drug Administration - Published 2020-06-26 - 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 model card (K200760)

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

    Scope: intendedUsers, output, limitations, evidenceSummary, 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 K200760

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

    Scope: postmarketSafety

Research history

  1. K200760 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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