Radiology AI Directory

FDA-cleared profile

FastStroke, CT Perfusion 4D

GE Medical Systems SCS

FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement. The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.

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.

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
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement. The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Clinical-use display mirrors the best exact-submission purpose source because the reviewed FDA packet did not provide a more specific usable abstraction.

Intended users
Physicians
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Confirm the intended care setting, patient population, and service line.

Workflow role
Post-processing analysis
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

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

Required input
CT/CTA images or data involving Brain; consult the FDA labeling for exact protocol, series, and quality requirements.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

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

Output and human action
FastStroke outputs a single colorized view fusing vascular information from multiple time points to visualize presence or absence of collateral vessels in the brain. CT Perfusion 4D outputs parametric images displaying perfusion-related parameters including regional blood flow, regional blood volume, mean transit time, and capillary permeability. The CT Perfusion 4D also uses a deep learning algorithm to segment brain ventricles.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Clinical output reported in the exact-submission ACR model card.

Limitations
Exclusion criteria: Unspecified
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Limitations and supported-acquisition details reported in the exact-submission ACR model card.

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
K193289
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Anatomy
Brain
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Anatomy normalized from explicit exact-submission ACR model-card wording.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-11-12
  • 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
The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.

Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

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 2026-09-09

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 2026-09-09

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

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for FastStroke, CT Perfusion 4D; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
Study type: Stand-Alone Performance. Reference standard: Interpretation by Reviewing Clinician
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.

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.

FastStroke regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K193289
  • IndependenceIndependence not established

K193289

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 2026-09-09

No public price or quote for the exact K193289 configuration was established in this review.

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

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 K193289. 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 2026-09-09

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.

Automated sources checkedStatus
2026-09-09Last searched
21Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA and recall packets were prepared and identity matched, but no new clinical or performance claim was promoted in the conservative fallback. Existing exact-submission facts retain their original source status and applicability; candidate literature remains quarantined. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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 K193289: FastStroke, CT Perfusion 4D

    U.S. Food and Drug Administration - Published 2020-11-12 - Accessed 2026-09-09

    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. FastStroke model card (K193289)

    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 K193289

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

    Scope: postmarketSafety

Research history

  1. K193289 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    automated sources checked

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