StrokeViewer Perfusion

JSON twin: https://www.healthaidb.com/software/strokeviewer-perfusion.json

Company Name

NICo-Lab

Product URL

https://www.nico-lab.com

Company URL

https://www.nico-lab.com

Categories

• clinical Care
• diagnostic Support
• imaging Software
• neurology
• Clinical
• Diagnostic
• Imaging
• Stroke Care

Summary

StrokeViewer Perfusion is a software solution that analyzes brain CT perfusion scans to assist in diagnosing ischemic stroke by providing quantitative blood flow and volume data.

Description

StrokeViewer Perfusion is an FDA-cleared image processing software developed by NICo-Lab B.V. It analyzes dynamic brain CT perfusion scans to provide quantitative information about cerebral blood flow and volume, aiding medical professionals in evaluating suspected ischemic stroke patients. The software generates perfusion maps and numerical data to inform diagnosis and treatment decisions, complementing clinical judgment without replacing it. It supports clinicians by producing additional imaging data to assist in the evaluation of suspected ischemic stroke patients. The software is designed to run on standard or virtual computer platforms and processes DICOM-compliant CT perfusion imaging data. It calculates perfusion parameters including cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), Tmax, and arterial input function (AIF), producing parametric maps and volumetric measurements which are output as DICOM series and reports. StrokeViewer Perfusion is intended for use by medical imaging professionals, including neurologists and radiologists, who analyze dynamic perfusion studies. It is part of NICo-Lab's StrokeViewer platform, which includes various tools to support the entire stroke workflow, such as LVO detection, hemorrhage detection, collateral assessment, and 3D treatment planning. The software is CE-marked and FDA-cleared, indicating compliance with European and U.S. regulatory standards. It is available in multiple countries, including the United States, Australia, and Europe, and supports multiple languages. The pricing model is subscription-based, with details available upon request. The company, NICo-Lab B.V., was founded in 2015 and has offices in the Netherlands and the United States.

Api Available

unknown

Certifications

• FDA 510(k) clearance (K231570)
• CE mark
• TGA approvals

Company Founding

2015

Company Offices

• Netherlands
• United States

Compliance

• FDA 510(k)
• CE marking
• TGA

Customers

Data Residency

Hosted on Google Cloud; regional cloud hosting options (US/EU) available

Data Standards

• DICOM
• HL7 v2

Deployment Model

• SaaS
• cloud-native

Features

• AI-driven large vessel occlusion (LVO) detection and triage
• CT/MR perfusion analysis with quantitative perfusion maps
• Certified mobile DICOM viewer for full series review
• Automated case forwarding across regional stroke network
• Push notifications/alerts to stroke teams
• Secure image sharing and study access anywhere
• PACS integration with automatic results return to PACS
• Remote diagnosis support (mobile/desktop)
• Automated image processing pipeline (cloud)
• Dashboards and metrics for stroke workflow performance
• Study-level reporting and numeric outputs
• Weekly cloud updates and model improvements
• Vendor-agnostic integration with CT scanners and imaging devices
• Inter-hospital study transfer and routing
• Audit trail and activity logging

Id

SW0280

Integration Partners

Integrations

• PACS (local hospital PACS)
• CT scanners
• MRI scanners (partner/device integrations)
• Philips (strategic partner/integration)
• Google Cloud (infrastructure)
• Hospital ADFS / SSO

Languages Supported

• English
• Dutch
• German
• French
• Spanish
• Italian
• Portuguese
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Javanese
• Turkish
• Vietnamese
• Telugu
• Marathi

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Perfusion analysis module
• LVO detection module
• Enterprise analytics / dashboards
• Regional image sharing / network routing

Os Platforms

• Web
• iOS
• Android

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• BAA available
• HIPAA-compliant handling
• Data minimization/anonymization options

Product Code

SW0280

Product Name

StrokeViewer Perfusion

Ratings

Regions Available

• United States
• Australia
• Europe

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption in transit (TLS)
• SSO/ADFS integration
• Role-based access control (RBAC)
• Audit logs
• Secure DICOM transfer

Specialties

• Neurology
• Radiology
• Emergency Medicine
• Stroke Care

Support Channels

System Requirements

Cloud-hosted SaaS; mobile apps for iOS/Android; integrates with hospital ADFS/SSO; no dedicated on-prem hardware required

Target Users

• Neurologists
• Radiologists
• Medical Imaging Professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "StrokeViewer Perfusion",
  "company_name": "NICo-Lab",
  "product_url": "https://www.nico-lab.com",
  "company_url": "https://www.nico-lab.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0280",
  "summary": "StrokeViewer Perfusion is a software solution that analyzes brain CT perfusion scans to assist in diagnosing ischemic stroke by providing quantitative blood flow and volume data.",
  "description": "StrokeViewer Perfusion is an FDA-cleared image processing software developed by NICo-Lab B.V. It analyzes dynamic brain CT perfusion scans to provide quantitative information about cerebral blood flow and volume, aiding medical professionals in evaluating suspected ischemic stroke patients. The software generates perfusion maps and numerical data to inform diagnosis and treatment decisions, complementing clinical judgment without replacing it. It supports clinicians by producing additional imaging data to assist in the evaluation of suspected ischemic stroke patients. The software is designed to run on standard or virtual computer platforms and processes DICOM-compliant CT perfusion imaging data. It calculates perfusion parameters including cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), Tmax, and arterial input function (AIF), producing parametric maps and volumetric measurements which are output as DICOM series and reports. StrokeViewer Perfusion is intended for use by medical imaging professionals, including neurologists and radiologists, who analyze dynamic perfusion studies. It is part of NICo-Lab's StrokeViewer platform, which includes various tools to support the entire stroke workflow, such as LVO detection, hemorrhage detection, collateral assessment, and 3D treatment planning. The software is CE-marked and FDA-cleared, indicating compliance with European and U.S. regulatory standards. It is available in multiple countries, including the United States, Australia, and Europe, and supports multiple languages. The pricing model is subscription-based, with details available upon request. The company, NICo-Lab B.V., was founded in 2015 and has offices in the Netherlands and the United States.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "imaging Software",
    "neurology",
    "Clinical",
    "Diagnostic",
    "Imaging",
    "Neurology",
    "Stroke Care"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Neurologists",
    "Radiologists",
    "Medical Imaging Professionals"
  ],
  "specialties": [
    "Neurology",
    "Radiology",
    "Emergency Medicine",
    "Stroke Care"
  ],
  "regions_available": [
    "United States",
    "Australia",
    "Europe"
  ],
  "languages_supported": [
    "English",
    "Dutch",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Portuguese",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Javanese",
    "Turkish",
    "Vietnamese",
    "Telugu",
    "Marathi"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "Netherlands",
    "United States"
  ],
  "company_founding": "2015",
  "deployment_model": [
    "SaaS",
    "cloud-native"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "AI-driven large vessel occlusion (LVO) detection and triage",
    "CT/MR perfusion analysis with quantitative perfusion maps",
    "Certified mobile DICOM viewer for full series review",
    "Automated case forwarding across regional stroke network",
    "Push notifications/alerts to stroke teams",
    "Secure image sharing and study access anywhere",
    "PACS integration with automatic results return to PACS",
    "Remote diagnosis support (mobile/desktop)",
    "Automated image processing pipeline (cloud)",
    "Dashboards and metrics for stroke workflow performance",
    "Study-level reporting and numeric outputs",
    "Weekly cloud updates and model improvements",
    "Vendor-agnostic integration with CT scanners and imaging devices",
    "Inter-hospital study transfer and routing",
    "Audit trail and activity logging"
  ],
  "optional_modules": [
    "Perfusion analysis module",
    "LVO detection module",
    "Enterprise analytics / dashboards",
    "Regional image sharing / network routing"
  ],
  "integrations": [
    "PACS (local hospital PACS)",
    "CT scanners",
    "MRI scanners (partner/device integrations)",
    "Philips (strategic partner/integration)",
    "Google Cloud (infrastructure)",
    "Hospital ADFS / SSO"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2"
  ],
  "api_available": "unknown",
  "system_requirements": "Cloud-hosted SaaS; mobile apps for iOS/Android; integrates with hospital ADFS/SSO; no dedicated on-prem hardware required",
  "compliance": [
    "FDA 510(k)",
    "CE marking",
    "TGA"
  ],
  "certifications": [
    "FDA 510(k) clearance (K231570)",
    "CE mark",
    "TGA approvals"
  ],
  "security_features": [
    "Encryption in transit (TLS)",
    "SSO/ADFS integration",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Secure DICOM transfer"
  ],
  "privacy_features": [
    "BAA available",
    "HIPAA-compliant handling",
    "Data minimization/anonymization options"
  ],
  "data_residency": "Hosted on Google Cloud; regional cloud hosting options (US/EU) available",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0280",
  "slug": "strokeviewer-perfusion",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/strokeviewer-perfusion.json"
  }
}