Radiology AI Directory

FDA-cleared profile

StrokeViewer Perfusion

NICo-Lab B.V.

Provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients using dynamic brain CT perfusion studies; medical imaging professionals use the information as additional data in the standard-of-care assessment, not as a standalone diagnostic tool.

Stroke and ICH triageQuantification and segmentation
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
Provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients using dynamic brain CT perfusion studies; medical imaging professionals use the information as additional data in the standard-of-care assessment, not as a standalone diagnostic tool.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Medical imaging professionals who analyze dynamic perfusion studies, including neurologists and radiologists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Clinical setting not specified in the FDA packet; adult suspected-stroke population
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-acquisition CT-perfusion viewing, processing, and quantitative analysis as an adjunct to standard-of-care interpretation; the output is reviewed in the clinical context and is not standalone diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM-compliant dynamic brain CT perfusion images from suspected ischemic-stroke patients in the adult population. The FDA comparison states that this submission does not support CTA or MR data for the Perfusion algorithm.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Colored perfusion maps and quantitative Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), Mean Transit Time (MTT), residue-function time-to-peak (TMax), Arterial Input Function (AIF), and affected-tissue volume calculations based on TMax and CBF abnormalities; results are exported as DICOM series and DICOM reports to a preconfigured destination for compatible DICOM-viewer review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not a standalone diagnostic tool and must be interpreted with patient information. The Perfusion algorithm is limited to brain CT perfusion rather than CTA or MR. The FDA indication identifies absent or inadequate bolus, excessive motion causing technically inadequate scans, and hemorrhage as contraindications; the packet does not establish a specific current PACS, RIS, EHR, or deployment configuration.
  • 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
K231570
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-12-14
  • 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 software is packaged as a Docker container for a standard off-the-shelf computer or virtual platform, extracts DICOM information, and exports DICOM series and reports to a preconfigured destination for compatible DICOM-viewer review. Exact current interface, PACS/RIS/EHR, and deployment details are not established.
  • 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.

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 StrokeViewer Perfusion; 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 K231570 states that clinical data were not required. Nonclinical verification and validation included unit, end-to-end, and reproducibility testing, plus bench performance testing on simulated Kudo digital-phantom datasets comparing device output with ground truth; the packet states that performance goals and acceptance criteria were met.
  • 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.

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 K231570 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 K231570. 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
2026-09-08Last searched
20Fields 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 scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. 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 K231570: StrokeViewer Perfusion

    U.S. Food and Drug Administration - Published 2023-12-14 - 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. StrokeViewer Perfusion model card (K231570)

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

    Scope: intendedUsers, careSetting, output, integration, anatomy, 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 K231570

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

    Scope: postmarketSafety

Research history

  1. K231570 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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