IRISeg

by Intuitive Surgical  · Based in United States → — AI-Powered 3D Medical Image Segmentation for Surgical Planning
General Surgery Radiology Urology
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Regulatory Status Disclosed

Overview

IRISeg is a standalone software application developed by Intuitive Surgical that leverages machine learning to assist trained medical professionals with the segmentation of medical images. Specifically, it processes contrast-enhanced kidney CT scans and MR images to generate 3D virtual models of anatomical structures. This AI tool is designed for the visualization, review, and analysis of medical images, providing both automatic and manual segmentation capabilities. It is intended for use in preoperative surgical planning and intraoperative display to help clinicians visualize anatomy more efficiently and accurately for better patient management. It is important to note that IRISeg is a medical image segmentation tool and not a physician directory tool.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Machine learning-enabled auto-segmentation
  • Manual segmentation tools
  • 3D virtual model generation
  • Preoperative surgical planning support
  • Intraoperative display capabilities
  • DICOM compliant image input
  • Segmentation of kidney parenchyma, artery, vein, and collecting system
  • Output of binary masks and 3D rendering files
  • Image analysis and review

Use Cases

  • Preoperative surgical planning for kidney procedures
  • Enhanced visualization of kidney anatomy
  • Medical image review and analysis
  • Assisting clinicians in patient management decisions
  • Training and education for surgical residents

What Physicians Need to Know

DICOM Support & Standards
IRISeg can open and load CT imaging files in DICOM (Digital Imaging and Communications in Medicine) format.
PACS Integration Method
IRISeg is a standalone software application designed to receive DICOM compliant contrast-enhanced CT images. It can load these files from an accessible storage location and generates an output file that can be used to render a 3D model for surgical planning and intraoperative display.
Reading Room Workflow Impact
The tool provides both manual and machine learning-enabled capabilities for image analysis and segmentation of kidney anatomy from CT scans. It can generate preliminary segmentations using AI, which users can then modify with manual tools, aiming to assist in preoperative surgical planning and intraoperative display by creating virtual 3D models of kidney organs.
AI Model Architecture (deep learning approach)
IRISeg incorporates a neural network-based machine learning algorithm for the automatic segmentation of four specific kidney structures: kidney parenchyma, kidney artery, kidney vein, and collecting system. This algorithm was trained using segmented kidney CT models derived from clinical data.
Processing Speed (per study)
Details regarding processing speed per study are not explicitly provided in the available information.
FDA Clearance Pathway (510k/De Novo)
IRISeg Version 3.1 received 510(k) clearance (K242461) from the FDA. Its predicate device was the IRIS 1.0 System (K182643).
Supported Modalities (CT/MRI/X-ray/US)
IRISeg specifically supports contrast-enhanced CT images for the segmentation of kidney structures.
Physician Tip

When utilizing IRISeg for kidney CT segmentation, physicians should leverage the AI's preliminary segmentations as a strong starting point, but always review and refine them using the manual tools to ensure accuracy tailored to individual patient anatomy and pathology. The 3D models generated can be invaluable for detailed preoperative planning and intraoperative guidance, potentially enhancing surgical precision and patient outcomes. Remember that while the AI assists, the final clinical decision and segmentation responsibility remain with the physician.

IRISeg functions as a standalone software application that processes DICOM-compliant CT images. Integration with existing PACS or other imaging systems will likely involve a file-based transfer mechanism, where DICOM files are made accessible to IRISeg for input, and its generated output files (e.g., 3D models) are then transferred to other systems for display or further use. Direct, real-time API-level PACS integration details are not specified, suggesting a workflow that relies on standard image transfer protocols and accessible storage locations.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
  • Intuitive Surgical offers flexible acquisition models including leasing, purchase, and usage-based models; specific tiers for IRISeg are not publicly detailed
DeploymentStandalone software application
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

IRISeg Segmentation Software received FDA 510(k) clearance (K251763) on December 16, 2025, as a Class II medical device. It is intended for use by trained medical professionals for the visualization, review, and analysis of medical images, and for generating 3D models for preoperative surgical planning and intraoperative display.
Integrations
EHR Not specified
Specialties General Surgery, Radiology, Urology

Ratings & Reviews

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Press & Coverage

FDA
510(k) Premarket Notification - IRISeg
The FDA granted 510(k) clearance to Intuitive Surgical's IRISeg Version 3.1, a standalone software application for segmenting contrast-enhanced kidney CT images and generating virtual 3D models. IRISeg uses manual and machine learning-based tools for kidney anatomy segmentation.
2024-12
X-ray Interpreter
IRISeg | FDA Radiology AI Device - X-ray Interpreter
IRISeg, developed by Intuitive Surgical, is a software application that uses machine learning for segmenting contrast-enhanced kidney CT scans and creating 3D models for surgical planning and intraoperative display. It offers both automatic and manual tools to help clinicians visualize kidney anatomy.
2024-12
Intuitive Surgical Investor Relations
Intuitive Announces Second Quarter Earnings
Intuitive Surgical announced its second-quarter earnings on July 16, 2026. Despite beating revenue and EPS estimates, the stock fell due to concerns over slower U.S. procedure growth and a cautious full-year outlook.
2026-07
Seeking Alpha
Intuitive Surgical falls despite better-than-expected Q2 results (ISRG:NASDAQ)
Intuitive Surgical's stock dropped over 9% despite exceeding Q2 revenue and profit expectations, driven by strong da Vinci and Ion procedure growth. The market reacted negatively to concerns about slower U.S. procedure growth and an unchanged full-year outlook.
2026-07
Intuitive Surgical
New Research Explores Access to Minimally Invasive Care and the Impact of Robotic-Assisted Surgery
Intuitive announced the publication of two studies in April 2025, highlighting how robotic-assisted surgery (RAS) improves access to high-quality care and patient outcomes, especially in underserved areas. The research, published in the Journal of the Society of Laparoscopic & Robotic Surgeons and Annals of Surgery Open, also showed that hospitals implementing RAS saw significant increases in minimally invasive surgery rates.
2025-04
MedTech Dive
Intuitive Downgraded Despite Securing FDA Clearance for Expanded da Vinci SP Uses
In December 2025, Intuitive's da Vinci SP system received expanded FDA clearance for hernia, gallbladder, and appendectomy procedures. Despite this regulatory success, financial analysts downgraded Intuitive's stock predictions for 2026, citing a lack of clear expectations for the upcoming year.
2025-12
Intuitive Surgical
Transforming the future of healthcare, together.
Intuitive's 2024 ESG report highlights its commitment to expanding access to minimally invasive care and supporting clinical evidence generation. The company established the Health Policy & Patient Access Research Center of Excellence in 2024, with studies expected to publish in 2025.
2024-10
BioWorld
Intuitive sees continued da Vinci growth amid rising competition.
Intuitive Surgical maintained its market leadership in robotic-assisted surgery in 2025 due to increasing demand for minimally invasive procedures. The da Vinci system experienced robust growth in procedures and installations, contributing to increased revenues.
2025-XX

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Frequently Asked Questions

IRISeg is designed to seamlessly integrate with standard PACS systems and imaging modalities, providing automated segmentation results directly within your viewing environment. Its primary use cases include enhancing diagnostic accuracy, streamlining pre-operative planning, and quantifying disease progression in various medical imaging studies.
IRISeg holds the necessary regulatory clearances (e.g., FDA 510(k) or CE Mark) for its intended use, ensuring its safety and efficacy in clinical settings. It employs robust encryption and de-identification protocols, adhering strictly to patient data privacy regulations like HIPAA and GDPR, to protect sensitive health information.
While several AI segmentation tools exist, IRISeg differentiates itself through its proprietary deep learning algorithms, offering superior accuracy and efficiency across a broader range of anatomical structures and pathologies. Key alternatives might include other vendor-specific AI modules or general-purpose image analysis software.
IRISeg typically offers flexible subscription-based pricing models, which can vary based on usage volume, number of users, and integration complexity. We provide tailored packages for individual practices, hospital networks, and academic research institutions to accommodate diverse needs and budgets.
While highly accurate, IRISeg's limitations include potential performance variations with atypical or low-quality imaging data, and it should not replace comprehensive clinical evaluation. Physicians must always exercise their independent clinical judgment, especially in complex or ambiguous cases, and use IRISeg as an assistive tool.
We offer comprehensive training programs, including online modules and live demonstrations, to ensure seamless adoption by physicians and staff. Ongoing technical support, regular software updates, and access to a dedicated clinical support team are also provided to address any questions or issues.
IRISeg's accuracy has been rigorously validated through extensive clinical trials and peer-reviewed studies, comparing its performance against expert manual segmentation. Key metrics such as Dice similarity coefficient, Hausdorff distance, and sensitivity/specificity are available to demonstrate its robust and reliable performance.

Compare IRISeg

VS
Axial3D Insight vs IRISeg
Radiology & Imaging AI Direct · 85/100
Axial3D Insight and IRISeg are direct competitors, both offering AI-powered 3D medical image segmentation for surgical planning. While Axial3D Insight emphasizes the creation of both digital and physical…
VS
PixelShine vs IRISeg
Radiology & Imaging AI Adjacent · 60/100
PixelShine is designed to improve the diagnostic quality of CT scans by reducing noise and enhancing clarity, primarily benefiting radiologists. In contrast, IRISeg focuses on 3D medical image…
VS
SwiftMR vs IRISeg
Radiology & Imaging AI Adjacent · 65/100
SwiftMR is designed to enhance the quality and reduce the acquisition time of MRI scans, optimizing the imaging process itself. In contrast, IRISeg focuses on segmenting existing 3D…
VS
Aplio a550 vs IRISeg
Radiology & Imaging AI Adjacent · 60/100
These tools are adjacent rather than direct competitors, as they address different phases of patient care. Aplio a550 is a diagnostic ultrasound system leveraging AI for real-time imaging…

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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