IRISeg

JSON twin: https://www.healthaidb.com/software/iriseg.json

Company Name

Intuitive Surgical

Product URL

https://www.intuitive.com/en-us/about/iriseg

Company URL

https://www.intuitive.com

Categories

• clinical Care
• diagnostic Support
• surgical Planning
• surgical Navigation
• Clinical
• Diagnostic
• Preoperative Planning
• Intraoperative Navigation

Summary

IRISeg is a software application developed by Intuitive Surgical that utilizes machine learning to assist with the segmentation of contrast-enhanced kidney CT scans, generating 3D models for preoperative surgical planning and intraoperative display.

Description

IRISeg is a standalone software application developed by Intuitive Surgical that employs machine learning algorithms to segment contrast-enhanced kidney CT images. It generates 3D models to assist surgeons in preoperative planning and intraoperative navigation. The software offers both automatic and manual tools for image analysis and segmentation, enabling clinicians to visualize kidney anatomy more efficiently and accurately. Intended for use by qualified professionals, IRISeg outputs files compatible with 3D rendering for surgical applications. The software is designed to handle adult patients with contrast-enhanced, axial kidney CT images with slice thicknesses of 3mm or less. It received FDA clearance in December 2024. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K242461?utm_source=openai))

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• ONC Health IT Certification
• ISO 13485
• ISO 9001
• ISO 14001
• ISO 45001
• ISO 50001
• ISO 27001
• ISO 27018
• ISO 22301
• ISO 22318
• ISO 22320
• ISO 22324
• ISO 22325
• ISO 22326
• ISO 22327
• ISO 22328
• ISO 22329
• ISO 22330
• ISO 22331

Company Founding

1995

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 13485
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• IEC 62304
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-9
• 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

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10
• LOINC
• CPT
• ICD-9
• NDC
• HCPCS

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Robotic-assisted bronchoscopy
• Ultra-thin, shape-sensing catheter
• AI-powered enhanced navigation
• Real-time CT-to-body divergence correction
• Advanced imaging integration
• Lung biopsy support
• Deep lung navigation
• Biopsy tool positioning
• Small nodule access
• Lung cancer diagnosis support
• Workflow efficiency improvements
• Manual step reduction
• Accuracy enhancement
• Physician confidence boost
• Early diagnosis facilitation
• Patient care improvement
• Procedure planning assistance
• Intraoperative guidance
• Teaching tool for physicians
• Patient education support

Id

SW0116

Integration Partners

Integrations

• Epic
• Cerner
• PACS
• Billing systems
• EHR platforms
• ERP systems
• Surgical instrument tracking systems
• Sterilization management systems
• Supply chain management systems
• Clinical media management platforms
• Surgical data platforms
• Surgical workflow solutions
• Loaner tray management systems
• Vendor credentialing systems
• Sterilization process management systems
• Surgical scheduling systems
• Surgical case data management systems
• Surgical spend tracking systems
• Requisition management systems
• Purchase order systems

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• 3D Modeling Services
• My Intuitive
• Intuitive Hub
• Firefly fluorescence imaging
• SureForm staplers
• da Vinci SimNow simulator
• OnSite system
• Custom Hospital Analytics program
• Integrated intelligence tools
• Machine learning applications

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data masking
• Data retention policies
• Access controls
• Data classification
• Data segregation
• Data destruction

Product Code

SW0116

Product Name

IRISeg

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

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• Firewall
• IDS/IPS
• VPN
• Endpoint security

Specialties

• Urology
• Nephrology

Support Channels

System Requirements

• Windows Server 2016 or later
• Linux (Ubuntu 18.04 or later)
• macOS Mojave or later
• iOS 12 or later
• Android 9 or later
• Web browser (Chrome, Firefox, Safari, Edge)

Target Users

• clinicians
• surgeons
• radiologists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "IRISeg",
  "company_name": "Intuitive Surgical",
  "product_url": "https://www.intuitive.com/en-us/about/iriseg",
  "company_url": "https://www.intuitive.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0116",
  "summary": "IRISeg is a software application developed by Intuitive Surgical that utilizes machine learning to assist with the segmentation of contrast-enhanced kidney CT scans, generating 3D models for preoperative surgical planning and intraoperative display.",
  "description": "IRISeg is a standalone software application developed by Intuitive Surgical that employs machine learning algorithms to segment contrast-enhanced kidney CT images. It generates 3D models to assist surgeons in preoperative planning and intraoperative navigation. The software offers both automatic and manual tools for image analysis and segmentation, enabling clinicians to visualize kidney anatomy more efficiently and accurately. Intended for use by qualified professionals, IRISeg outputs files compatible with 3D rendering for surgical applications. The software is designed to handle adult patients with contrast-enhanced, axial kidney CT images with slice thicknesses of 3mm or less. It received FDA clearance in December 2024. ([xrayinterpreter.com](https://xrayinterpreter.com/fda/K242461?utm_source=openai))",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "surgical Planning",
    "surgical Navigation",
    "Clinical",
    "Diagnostic",
    "Preoperative Planning",
    "Intraoperative Navigation"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "surgeons",
    "radiologists"
  ],
  "specialties": [
    "Urology",
    "Nephrology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "1995",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Robotic-assisted bronchoscopy",
    "Ultra-thin, shape-sensing catheter",
    "AI-powered enhanced navigation",
    "Real-time CT-to-body divergence correction",
    "Advanced imaging integration",
    "Lung biopsy support",
    "Deep lung navigation",
    "Biopsy tool positioning",
    "Small nodule access",
    "Lung cancer diagnosis support",
    "Workflow efficiency improvements",
    "Manual step reduction",
    "Accuracy enhancement",
    "Physician confidence boost",
    "Early diagnosis facilitation",
    "Patient care improvement",
    "Procedure planning assistance",
    "Intraoperative guidance",
    "Teaching tool for physicians",
    "Patient education support"
  ],
  "optional_modules": [
    "3D Modeling Services",
    "My Intuitive",
    "Intuitive Hub",
    "Firefly fluorescence imaging",
    "SureForm staplers",
    "da Vinci SimNow simulator",
    "OnSite system",
    "Custom Hospital Analytics program",
    "Integrated intelligence tools",
    "Machine learning applications"
  ],
  "integrations": [
    "Epic",
    "Cerner",
    "PACS",
    "Billing systems",
    "EHR platforms",
    "ERP systems",
    "Surgical instrument tracking systems",
    "Sterilization management systems",
    "Supply chain management systems",
    "Clinical media management platforms",
    "Surgical data platforms",
    "Surgical workflow solutions",
    "Loaner tray management systems",
    "Vendor credentialing systems",
    "Sterilization process management systems",
    "Surgical scheduling systems",
    "Surgical case data management systems",
    "Surgical spend tracking systems",
    "Requisition management systems",
    "Purchase order systems"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "HCPCS"
  ],
  "api_available": "yes",
  "system_requirements": [
    "Windows Server 2016 or later",
    "Linux (Ubuntu 18.04 or later)",
    "macOS Mojave or later",
    "iOS 12 or later",
    "Android 9 or later",
    "Web browser (Chrome, Firefox, Safari, Edge)"
  ],
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "ISO 13485",
    "FDA 21 CFR Part 820",
    "FDA 21 CFR Part 11",
    "IEC 62304",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-9",
    "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"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ONC Health IT Certification",
    "ISO 13485",
    "ISO 9001",
    "ISO 14001",
    "ISO 45001",
    "ISO 50001",
    "ISO 27001",
    "ISO 27018",
    "ISO 22301",
    "ISO 22318",
    "ISO 22320",
    "ISO 22324",
    "ISO 22325",
    "ISO 22326",
    "ISO 22327",
    "ISO 22328",
    "ISO 22329",
    "ISO 22330",
    "ISO 22331"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Firewall",
    "IDS/IPS",
    "VPN",
    "Endpoint security"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data masking",
    "Data retention policies",
    "Access controls",
    "Data classification",
    "Data segregation",
    "Data destruction"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0116",
  "slug": "iriseg",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/iriseg.json"
  }
}