NvisionVLE Imaging System

JSON twin: https://www.healthaidb.com/software/nvisionvle-imaging-system.json

Company Name

Intelligent Retinal Imaging Systems

Product URL

https://www.intelligentretinal.com

Company URL

https://www.intelligentretinal.com

Categories

• diagnostic Support
• clinical Care
• administrative Operations
• Diagnostic
• Clinical
• Administrative

Summary

The NvisionVLE Imaging System is an optical coherence tomography (OCT) device that provides real-time, high-resolution cross-sectional images of tissue microstructures, aiding in the detection of diseases not visible with conventional imaging methods.

Description

The NvisionVLE Imaging System utilizes optical coherence tomography (OCT) technology to produce real-time, high-resolution cross-sectional images of tissue microstructures. It is designed to assist clinicians in evaluating tissue surfaces and subsurfaces for potential diseases that may not be detectable with traditional imaging techniques such as endoscopy and ultrasound. The system has received FDA clearance for imaging esophageal tissue and has been expanded to include applications for the pancreas and bile duct. Additionally, the system features the Intelligent Real-time Image Segmentation (IRIS) software, an AI-based platform that enhances image feature segmentation, marking the first of its kind approved for imaging esophageal tissue. This advancement aims to improve biopsy targeting and treatment planning by providing more complete information to clinicians during endoscopic procedures.

Api Available

no

Certifications

• FDA 510(k) clearance
• CE Mark approval
• ISO 13485:2003 certification

Company Founding

2009

Company Offices

• United States

Compliance

• FDA 510(k) clearance
• CE Mark approval
• ISO 13485:2003 certification

Customers

Data Residency

US/EU regions

Data Standards

• DICOM

Deployment Model

• on_prem

Features

• Real-time high-resolution cross-sectional imaging
• Volumetric Laser Endomicroscopy (VLE)
• Optical Coherence Tomography (OCT) technology
• Real-time Targeting feature for tissue marking
• Artificial Intelligence-based image segmentation (IRIS)
• Enhanced biopsy targeting
• Evaluation of esophageal tissue microstructure
• Cross-sectional and longitudinal imaging views
• High-speed optical probe with balloon catheter
• User-friendly touch-screen monitor interface
• Hand-controller for real-time scan control
• Single and double mark options for tissue marking
• Compatibility with endoscope channels 2.8mm or larger
• Advanced image processing algorithms
• Real-time visualization of tissue features
• Improved diagnostic confidence
• Streamlined endoscopic procedures
• High-resolution imaging up to 3mm depth
• Enhanced workflow for clinicians

Id

SW0002

Integration Partners

Integrations

• Endoscope systems
• Medical imaging devices

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• IRIS software upgrade for AI-based image segmentation

Os Platforms

• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Data anonymization
• Consent management

Product Code

SW0002

Product Name

NvisionVLE Imaging System

Ratings

Regions Available

• United States

Related Urls

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

Release Year

Security Features

• Data encryption
• User authentication
• Audit logs

Specialties

• Gastroenterology
• Oncology
• Radiology

Support Channels

System Requirements

Windows, macOS, Linux

Target Users

• clinicians
• gastroenterologists
• pathologists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "NvisionVLE Imaging System",
  "company_name": "Intelligent Retinal Imaging Systems",
  "product_url": "https://www.intelligentretinal.com",
  "company_url": "https://www.intelligentretinal.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0002",
  "summary": "The NvisionVLE Imaging System is an optical coherence tomography (OCT) device that provides real-time, high-resolution cross-sectional images of tissue microstructures, aiding in the detection of diseases not visible with conventional imaging methods.",
  "description": "The NvisionVLE Imaging System utilizes optical coherence tomography (OCT) technology to produce real-time, high-resolution cross-sectional images of tissue microstructures. It is designed to assist clinicians in evaluating tissue surfaces and subsurfaces for potential diseases that may not be detectable with traditional imaging techniques such as endoscopy and ultrasound. The system has received FDA clearance for imaging esophageal tissue and has been expanded to include applications for the pancreas and bile duct. Additionally, the system features the Intelligent Real-time Image Segmentation (IRIS) software, an AI-based platform that enhances image feature segmentation, marking the first of its kind approved for imaging esophageal tissue. This advancement aims to improve biopsy targeting and treatment planning by providing more complete information to clinicians during endoscopic procedures.",
  "categories": [
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    "clinical Care",
    "administrative Operations",
    "Diagnostic",
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    "Administrative"
  ],
  "market_segment": [
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    "smb"
  ],
  "target_users": [
    "clinicians",
    "gastroenterologists",
    "pathologists"
  ],
  "specialties": [
    "Gastroenterology",
    "Oncology",
    "Radiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2009",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time high-resolution cross-sectional imaging",
    "Volumetric Laser Endomicroscopy (VLE)",
    "Optical Coherence Tomography (OCT) technology",
    "Real-time Targeting feature for tissue marking",
    "Artificial Intelligence-based image segmentation (IRIS)",
    "Enhanced biopsy targeting",
    "Evaluation of esophageal tissue microstructure",
    "Cross-sectional and longitudinal imaging views",
    "High-speed optical probe with balloon catheter",
    "User-friendly touch-screen monitor interface",
    "Hand-controller for real-time scan control",
    "Single and double mark options for tissue marking",
    "Compatibility with endoscope channels 2.8mm or larger",
    "Advanced image processing algorithms",
    "Real-time visualization of tissue features",
    "Improved diagnostic confidence",
    "Streamlined endoscopic procedures",
    "High-resolution imaging up to 3mm depth",
    "Enhanced workflow for clinicians"
  ],
  "optional_modules": [
    "IRIS software upgrade for AI-based image segmentation"
  ],
  "integrations": [
    "Endoscope systems",
    "Medical imaging devices"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "no",
  "system_requirements": "Windows, macOS, Linux",
  "compliance": [
    "FDA 510(k) clearance",
    "CE Mark approval",
    "ISO 13485:2003 certification"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE Mark approval",
    "ISO 13485:2003 certification"
  ],
  "security_features": [
    "Data encryption",
    "User authentication",
    "Audit logs"
  ],
  "privacy_features": [
    "Data anonymization",
    "Consent management"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0002",
  "slug": "nvisionvle-imaging-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/nvisionvle-imaging-system.json"
  }
}