EW10-EC02 Endoscopy Support Program

JSON twin: https://www.healthaidb.com/software/ew10-ec02-endoscopy-support-program.json

Company Name

FUJIFILM

Product URL

https://www.fujifilm.com/products/medical/endoscopy/ew10-ec02

Company URL

https://www.fujifilm.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• Clinical
• Diagnostic
• Medical Imaging
• Artificial Intelligence

Summary

The EW10-EC02 Endoscopy Support Program is an AI-driven software developed by FUJIFILM Corporation to assist endoscopists in real-time detection of colonic mucosal lesions during colonoscopy procedures.

Description

The EW10-EC02 Endoscopy Support Program, known as CAD EYE, utilizes deep learning technology to analyze endoscopic images in real-time, aiding in the detection of colonic polyps and adenomas. It integrates with FUJIFILM's ELUXEO Endoscopic Imaging System, enhancing lesion detection capabilities during colonoscopy procedures. The system provides visual and auditory alerts when suspicious lesions are identified, supporting endoscopists in improving adenoma detection rates without increasing procedure time. CAD EYE is compatible with both White Light Imaging and Linked Color Imaging modes, offering flexibility in various clinical settings. Developed at FUJIFILM's Tokyo-based global AI technology center, the software underwent extensive validation, demonstrating high sensitivity for lesion detection and safety comparable to conventional colonoscopy methods. The system is designed to be unobtrusive, adding minimal visual cues to the endoscopic view to assist clinicians without distracting from the procedure. CAD EYE is intended to be used as a supplementary tool to enhance the detection and characterization of colonic lesions, supporting endoscopists in their clinical decision-making process.

Api Available

unknown

Certifications

• FDA 510(k) clearance
• CE mark
• ISO 13485
• ISO 14971
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24
• IEC 60601-1-25

Company Founding

1934

Company Offices

• Japan
• United States
• Germany
• France
• United Kingdom
• China
• India
• Brazil
• Australia
• South Korea

Compliance

• FDA 510(k) clearance
• HIPAA
• ISO 13485
• ISO 14971
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24
• IEC 60601-1-25

Customers

• Brigham and Women's Hospital

Data Residency

Japan, United States

Data Standards

• DICOM
• HL7
• FTP
• FTPS
• Samba

Deployment Model

• on_prem

Features

• Real-time detection of colonic mucosal lesions using AI deep learning technology
• Detection of flat lesions, multiple polyps, and lesions at the corner of the endoscopic view
• Visual and auditory alerts for detected polyps
• Integration with Fujifilm's ELUXEO Endoscopic Imaging System
• Compatibility with 700 series colonoscopes
• Storage of up to 30 hours of Full-HD video material
• Activation and deactivation via endoscope button or processor
• Support for White Light Imaging (WLI) and Linked Color Imaging (LCI) modes
• Characterization of polyps as hyperplastic or neoplastic using Blue Light Imaging (BLI)
• Automatic switching between detection and characterization modes based on observation mode

Id

SW0278

Integration Partners

• EndoSim

Integrations

• Fujifilm ELUXEO Endoscopic Imaging System
• 700 series colonoscopes

Languages Supported

• English
• Japanese
• German
• French
• Spanish
• Italian
• Chinese
• Korean
• Portuguese
• Russian

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• CAD EYE Characterization

Os Platforms

• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0278

Product Name

EW10-EC02 Endoscopy Support Program

Ratings

• CAD EYE is an evolution of Fujifilm’s ELUXEO Endoscopic Imaging System, featuring AI image processing functionality customized for the integration with the system’s processor and the endoscope.

Regions Available

• United States
• Japan
• Europe
• Asia
• North America

Related Urls

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

Release Year

2020

Security Features

• Encryption
• Role-Based Access Control (RBAC)
• Audit logs
• Two-Factor Authentication (2FA)
• Data Loss Prevention (DLP)

Specialties

• Gastroenterology
• Colorectal Surgery

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Fujifilm ELUXEO Endoscopic Imaging System, 700 series colonoscopes

Target Users

• Clinicians
• Endoscopists
• Medical Professionals

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• Having Fujifilm's Systems Integration platform in our endoscopy suite has dramatically reduced our procedure times as we no longer have to unplug wires, change system inputs, and worry about images not routing or showing up on the right monitors.

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "EW10-EC02 Endoscopy Support Program",
  "company_name": "FUJIFILM",
  "product_url": "https://www.fujifilm.com/products/medical/endoscopy/ew10-ec02",
  "company_url": "https://www.fujifilm.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0278",
  "summary": "The EW10-EC02 Endoscopy Support Program is an AI-driven software developed by FUJIFILM Corporation to assist endoscopists in real-time detection of colonic mucosal lesions during colonoscopy procedures.",
  "description": "The EW10-EC02 Endoscopy Support Program, known as CAD EYE, utilizes deep learning technology to analyze endoscopic images in real-time, aiding in the detection of colonic polyps and adenomas. It integrates with FUJIFILM's ELUXEO Endoscopic Imaging System, enhancing lesion detection capabilities during colonoscopy procedures. The system provides visual and auditory alerts when suspicious lesions are identified, supporting endoscopists in improving adenoma detection rates without increasing procedure time. CAD EYE is compatible with both White Light Imaging and Linked Color Imaging modes, offering flexibility in various clinical settings. Developed at FUJIFILM's Tokyo-based global AI technology center, the software underwent extensive validation, demonstrating high sensitivity for lesion detection and safety comparable to conventional colonoscopy methods. The system is designed to be unobtrusive, adding minimal visual cues to the endoscopic view to assist clinicians without distracting from the procedure. CAD EYE is intended to be used as a supplementary tool to enhance the detection and characterization of colonic lesions, supporting endoscopists in their clinical decision-making process.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "Clinical",
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    "Patient-facing",
    "Medical Imaging",
    "Artificial Intelligence"
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  "market_segment": [
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    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Endoscopists",
    "Medical Professionals"
  ],
  "specialties": [
    "Gastroenterology",
    "Colorectal Surgery"
  ],
  "regions_available": [
    "United States",
    "Japan",
    "Europe",
    "Asia",
    "North America"
  ],
  "languages_supported": [
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    "Japanese",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Chinese",
    "Korean",
    "Portuguese",
    "Russian"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "Japan",
    "United States",
    "Germany",
    "France",
    "United Kingdom",
    "China",
    "India",
    "Brazil",
    "Australia",
    "South Korea"
  ],
  "company_founding": "1934",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Real-time detection of colonic mucosal lesions using AI deep learning technology",
    "Detection of flat lesions, multiple polyps, and lesions at the corner of the endoscopic view",
    "Visual and auditory alerts for detected polyps",
    "Integration with Fujifilm's ELUXEO Endoscopic Imaging System",
    "Compatibility with 700 series colonoscopes",
    "Storage of up to 30 hours of Full-HD video material",
    "Activation and deactivation via endoscope button or processor",
    "Support for White Light Imaging (WLI) and Linked Color Imaging (LCI) modes",
    "Characterization of polyps as hyperplastic or neoplastic using Blue Light Imaging (BLI)",
    "Automatic switching between detection and characterization modes based on observation mode"
  ],
  "optional_modules": [
    "CAD EYE Characterization"
  ],
  "integrations": [
    "Fujifilm ELUXEO Endoscopic Imaging System",
    "700 series colonoscopes"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FTP",
    "FTPS",
    "Samba"
  ],
  "api_available": "unknown",
  "system_requirements": "Fujifilm ELUXEO Endoscopic Imaging System, 700 series colonoscopes",
  "compliance": [
    "FDA 510(k) clearance",
    "HIPAA",
    "ISO 13485",
    "ISO 14971",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24",
    "IEC 60601-1-25"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24",
    "IEC 60601-1-25"
  ],
  "security_features": [
    "Encryption",
    "Role-Based Access Control (RBAC)",
    "Audit logs",
    "Two-Factor Authentication (2FA)",
    "Data Loss Prevention (DLP)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "Japan, United States",
  "customers": [
    "Brigham and Women's Hospital"
  ],
  "user_reviews": [
    "Having Fujifilm's Systems Integration platform in our endoscopy suite has dramatically reduced our procedure times as we no longer have to unplug wires, change system inputs, and worry about images not routing or showing up on the right monitors."
  ],
  "ratings": [
    "CAD EYE is an evolution of Fujifilm’s ELUXEO Endoscopic Imaging System, featuring AI image processing functionality customized for the integration with the system’s processor and the endoscope."
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2020",
  "integration_partners": [
    "EndoSim"
  ],
  "id": "SW0278",
  "slug": "ew10-ec02-endoscopy-support-program",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/ew10-ec02-endoscopy-support-program.json"
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}