EFAI RTSUITE CT HCAP-Segmentation System

by Ever Fortune.AI Co.  · Based in Taiwan →Beyond Medicine. Anytime. Anywhere.
Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

The EFAI RTSUITE CT HCAP-Segmentation System is an AI-powered software tool developed by Ever Fortune.AI Co. to enhance the efficiency and accuracy of radiation therapy treatment planning. It is designed to assist trained radiation oncology professionals, including radiation oncologists, medical physicists, and dosimetrists, by automatically outlining critical organs at risk (OARs) on non-contrast CT images for adult patients. This standalone software leverages deep learning algorithms to process DICOM input images and generate RTSTRUCT output, which can then be integrated seamlessly with any DICOM-compliant radiation therapy treatment planning system (TPS). The system aims to significantly reduce the time-consuming manual contouring process, thereby accelerating clinical workflows and improving treatment timeliness. It has been clinically validated on a large dataset, demonstrating high accuracy in segmenting various anatomical structures across multiple body regions, including the head, neck, thorax, abdomen, and male pelvis. The latest version of the auto-contouring system integrates numerous critical anatomical structures, supporting automated contouring tasks for both CT and MR imaging, and offers delineation of up to 80 critical organ structures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered automatic outlining of organs at risk (OARs) on CT scans
  • Assists radiation oncology professionals in treatment planning
  • Processes DICOM input and generates RTSTRUCT output
  • Integrates with DICOM-compliant radiation therapy treatment planning systems (TPS)
  • Supports multiple body regions including head, neck, thorax, abdomen, and male pelvis
  • Validated on 1,846 adult cases with high accuracy (mean Dice Similarity Coefficient of 0.83)
  • Standalone software using deep learning algorithms
  • Delineates up to 80 critical organ structures
  • Enhances radiotherapy workflow efficiency
  • No user interface within the device itself; relies on integration with TPS

Use Cases

  • Radiation therapy treatment planning
  • Automated contouring of organs at risk (OARs)
  • Improving workflow efficiency in radiation oncology departments
  • Assisting radiation oncologists, medical physicists, and dosimetrists
  • Reducing manual contouring time

What Physicians Need to Know

Key Capabilities
Automates the delineation of 80 critical organs-at-risk (OARs) on CT images for radiation therapy planning, covering head, neck, chest, abdomen, and pelvis. Utilizes a hybrid 2D/3D deep learning architecture and visual transformers for enhanced segmentation accuracy.
Clinical Utility
Assists radiation oncology professionals (radiation oncologists, medical physicists, dosimetrists) by significantly reducing the time required for manual OAR contouring, thereby accelerating radiation therapy workflows and treatment planning. It is an adjunct tool, not a replacement for clinical judgment.
Integration Options
Highly compatible with any DICOM-compliant Treatment Planning System (TPS). It receives CT images in DICOM format and outputs contours as DICOM-RT Structure Sets, operating automatically in the background within a local hospital network.
Compliance Status
FDA cleared in the US (Class II medical device, 21 CFR 892.2050) and holds multiple approvals from Taiwan's FDA.
Pricing Model
Specific pricing model details are not publicly available, but AI tool implementations typically involve licensing fees and integration costs.
User Experience
Operates as a standalone software without a direct user interface; contours are generated automatically and then reviewed and edited within the existing DICOM-compliant treatment planning system, aiming for an efficient and less distracting workflow.
Implementation Complexity
Requires deployment within a local hospital network and installation on a specialized server capable of deep learning processing. Configuration settings are managed by the manufacturer.
Evidence Base
Developed and validated by China Medical University Hospital, with models strengthened by advanced deep learning architectures for improved accuracy. Studies indicate AI-driven segmentation can achieve accuracy comparable to manual methods while enhancing efficiency.
Physician Tip

This AI-powered system is designed to significantly streamline the organ-at-risk contouring process in radiation therapy planning, potentially saving considerable time. Remember that it functions as an *adjunct* tool; always review and manually adjust the automatically generated contours to ensure clinical accuracy and patient safety. Its broad anatomical coverage and compatibility with existing TPS make it a valuable addition to enhance workflow efficiency.

The system is built for seamless integration with existing DICOM-compliant Treatment Planning Systems (TPS). It operates as a backend service, receiving CT images and outputting RT Structure Sets. Ensure your hospital's IT infrastructure, including a local network and a dedicated server for deep learning, meets the deployment requirements for optimal performance.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentInstalled on specialized local servers.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Cleared on September 25, 2023, under 510(k) premarket notification (K231928) as a Class II device (21 CFR 892.2050) for Radiological Image Processing Software for Radiation Therapy.

Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

The EFAI RTSUITE CT HCAP-Segmentation System is a medical imaging software designed to automate the segmentation of various structures in CT scans, particularly focusing on head and neck regions. It aims to improve efficiency and accuracy for physicians by reducing manual segmentation time and providing quantitative analysis capabilities. While specific public reviews from physicians or tech review sites are limited, the technology generally aligns with the growing trend of AI in medical imaging for enhanced diagnostic and treatment planning workflows.

Overall: Mixed

Strengths

  • Automates segmentation, potentially saving significant physician time.
  • Aims to improve accuracy and consistency in measurements compared to manual methods.
  • Provides quantitative analysis, which can be valuable for treatment planning and monitoring.
  • Focuses on critical areas like head and neck, where precise segmentation is crucial.
  • Leverages AI to enhance medical imaging workflows.
  • Potentially reduces inter-observer variability in segmentation.

Limitations

  • Limited publicly available, independent physician reviews or detailed case studies.
  • Specific performance metrics (e.g., Dice score, processing time) are not readily available in general web searches.
  • Integration challenges with existing hospital PACS/RIS systems are common for new AI tools.
  • Potential for 'black box' concerns regarding AI decision-making without clear explainability.
  • Requires validation and trust from clinicians for widespread adoption.
  • Cost of implementation and ongoing maintenance might be a barrier for some institutions.

Based on reviews from: EverFortune.AI official website, General medical AI imaging trends and discussions, Academic papers on AI in medical image segmentation (general context)

Last updated: 2026-07-18

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Press & Coverage

Healthcare+ B2B
Ever Fortune.AI medical software nets one more approval for the US market
Ever Fortune.AI announced on September 26, 2025, that its u201cEFAI RT Suite CT HCAP-Segmentation Systemu201d received FDA approval. This medical software uses a closed-loop AI algorithm to automatically delineate 17 types of head-and-neck organs-at-risk on CT images, aiming to accelerate radiotherapy workflows.
2025-09
MarketScreener
Ever Fortune Says U.S. FDA Approves Launch Of EFAI Assessment System
Ever Fortune announced on February 21, 2025, that the U.S. FDA approved the launch of its EFAI Assessment System. This news is part of broader updates on Ever Fortune.AI Co., Ltd.'s financial results and other medical device approvals.
2025-02
FDA.report
EFAI RTSuite CT HCAP-Segmentation System
The EFAI RTSuite CT HCAP-Segmentation System (EFAI HCAPSeg) is a standalone software designed to assist radiation oncology professionals by automatically delineating organs-at-risk on CT images to facilitate radiation therapy workflows. It received FDA 510(k) clearance on September 25, 2023.
2023-09
China Medical University Hospital
Enhancing Radiotherapy Workflow Efficiency with Artificial Intelligence - EFAI RT Suite CT HCAP-Segmentation System
This system utilizes AI to assist radiation therapy by enhancing image quality, fusing multiple imaging modalities, and offering critical organ delineation before treatment. Developed and validated by China Medical University Hospital, the technology was transferred to Ever Fortune.AI Co., Ltd.
unknown
N Engl J Med
Artificial Intelligence in U.S. Health Care Delivery
This letter to the editor, published in the New England Journal of Medicine, lists EverFortune.AI and China Medical University Hospital as affiliations of the authors discussing Artificial Intelligence in U.S. Health Care Delivery.
2023-10
accessdata.fda.gov
EFAI RT Suite CT HN-Segmentation System
The EFAI RTSuite CT HN-Segmentation System, a predicate device to the HCAP-Segmentation System, is a standalone software for automatically delineating head-and-neck organs-at-risk on CT images to facilitate radiation therapy workflows. It received FDA 510(k) clearance on April 28, 2022.
2022-04
Frontiers
How smart is artificial intelligence in organs delineation? Testing a CE and FDA-approved Deep-Learning tool using multiple expert contours delineated on planning CT images
This peer-reviewed article discusses the evaluation of a CE- and FDA-approved Deep-Learning tool for automatic organ at risk (OARs) and clinical target volumes segmentation on CT images, highlighting the importance of external validation in real-world contexts.
2023-03
American College of Radiology
AI Central Market Updates for June 12, 2024
This update from the American College of Radiology mentions the EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) developed by Ever Fortune.AI Co., Ltd., as a newly cleared FDA product. It is a radiological computer-aided triage and notification software for analyzing chest or chest-abdomen CTA in adults.
2024-06

Videos

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Frequently Asked Questions

This system is a standalone AI software that receives DICOM CT images, automatically generates initial contours of organs-at-risk (OARs) using deep learning, and outputs them as DICOM-RTSTRUCT files. It integrates with your existing DICOM-compliant treatment planning system, where clinicians then review and edit the generated contours.
No, the EFAI RTSUITE CT HCAP-Segmentation System is designed as an adjunct tool to assist radiation oncology professionals, not to replace their judgment or manual contouring. Clinicians are required to review and make any necessary edits to the AI-generated contours before final approval.
The system has received FDA clearance in the US as a Class II medical device and approvals from Taiwan's FDA. It processes DICOM input and generates RTSTRUCT output, adhering to DICOM standards for image and data handling, which implies adherence to data security best practices for medical devices.
Several other AI-powered auto-segmentation tools are available, including solutions from MVision AI, Limbus AI, MIM Software, Varian Ethos, and RayStation. These systems also aim to enhance efficiency and consistency in radiation therapy planning by automating OAR contouring.
Specific pricing details for the EFAI RTSUITE CT HCAP-Segmentation System are not publicly available in the provided search results. Typically, such systems are offered through licensing agreements, which may involve upfront costs, annual subscriptions, or per-use fees, and often depend on the scale of deployment and included features.
The system's performance has been clinically validated, demonstrating high accuracy with a mean Dice Similarity Coefficient of 0.83 overall in independent CT cases. However, factors such as patient-specific anatomical variability, image quality, and scanner settings can influence the model's performance, necessitating clinician review and adjustment.
The EFAI RTSUITE CT HCAP-Segmentation System is intended for adult patients and is designed to delineate organs-at-risk on non-contrast CT images across multiple body regions, including the head, male pelvis, thorax, and abdomen. It is not intended for pediatric patients or for detecting lesions.

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