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
The EFAI RTSUITE CT HCAP-Segmentation System is an AI-powered auto-segmentation solution for radiation therapy planning. It automatically delineates organs-at-risk (OARs) on DICOM CT images. The latest version, Seg Pro V3 (RT-300), offers expanded coverage across Head & Neck, Thorax, Abdomen, and Pelvis, and supports automated contouring for both CT and MR imaging. It integrates numerous critical anatomical structures, including the optic nerve, hippocampus, vertebral bodies, gastrointestinal tract, adrenal glands, ribs, and iliopsoas muscles. The system uses a hybrid 2D/3D deep learning architecture combined with visual transformer models to improve segmentation accuracy.
Clinical Utility
This system is designed to enhance radiotherapy workflow efficiency by automating the time-consuming manual contouring process, which can improve speed and planning accuracy. It aims to assist trained radiation oncology professionals, including radiation oncologists, medical physicists, and dosimetrists, in radiation therapy planning. The auto-contouring of OARs facilitates radiation therapy workflows and helps reduce the time needed for treatment planning.
Integration Options
The system generates DICOM Radiotherapy Structure Sets (RTSS) with OAR contours, which are intended to be reviewed and edited using a DICOM-compliant treatment planning system (TPS). It is designed to be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications.
Compliance Status
The EFAI RTSUITE CT HCAP-Segmentation System (K231928) is FDA-cleared as a Radiological Image Processing Software for Radiation Therapy (Product Code QKB). Its successor, Seg Pro V3 (RT-300), was the first radiotherapy software (QKB) to receive FDA 510(k) clearance with a Predetermined Change Control Plan (PCCP), allowing adaptive AI model updates without regulatory re-submission.
User Experience
The system aims to promote a balance between speed, precision, and clinical adaptability, helping clinical teams improve overall treatment quality and efficiency. It is intended to be used by trained radiation oncology professionals.
Evidence Base
The models were strengthened through the application of a hybrid 2D/3D deep learning architecture combined with visual transformer models. The latest version's added structures were selected based on clinical needs, with direct involvement of radiation oncology specialists in both selection and annotation of training data. The system has undergone data development and validation by hospitals.
Physician Tip

This AI tool can significantly reduce the time spent on manual contouring of organs-at-risk in radiation therapy planning, allowing for more efficient workflows. However, always review and edit the automatically generated contours within your DICOM-compliant treatment planning system to ensure accuracy and patient safety. The expanded coverage of anatomical regions and support for both CT and MR imaging in the latest version can be particularly beneficial for comprehensive treatment planning.

The EFAI RTSUITE CT HCAP-Segmentation System is designed to integrate with existing DICOM-compliant treatment planning systems. It outputs DICOM RTSS files, which are standard for radiation therapy planning. This ensures compatibility with a wide range of clinical workflows and software.

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 Cleared AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

The EFAI RTSUITE CT HCAP-Segmentation System is a software device designed to assist radiation oncology professionals in treatment planning. It uses deep-learning algorithms to provide initial contours of organs at risk on non-contrast CT images, which are then transferred to radiation therapy treatment planning systems for review and editing. The system is intended as an adjunct tool and does not have its own user interface, relying on integration with existing DICOM-compliant systems.

Overall: Positive

Strengths

  • Assists trained radiation oncology professionals in radiation-treatment planning.
  • Provides initial deep-learning contours of organs at risk on non-contrast CT images.
  • Automates the contouring process, sending results as DICOM-RT Structure Sets.
  • Integrates with existing DICOM-compliant treatment planning systems.
  • FDA-cleared as a Class II medical device.

Limitations

  • Does not have its own user interface, requiring integration with other systems.
  • Not intended for decision-making or lesion detection.
  • Cannot replace a clinician's judgment and manual contouring.
  • Clinicians must review and edit the software-generated output; it cannot be used alone as the primary interpretation.
  • Intended for use on adult patients only.

Based on reviews from: fda.gov, parikhradiology.com, innolitics.com, fda.report

Last updated: 2026-10-30

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Press & Coverage

fda.gov
EFAI RTSUITE CT HCAP-Segmentation System
The EFAI RTSUITE CT HCAP-Segmentation System is a radiological image processing software for radiation therapy, classified as a Class 2 device by the FDA under product code QKB. It provides semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy, utilizing artificial intelligence including nonadaptive machine learning algorithms.
2026-10
innolitics.com
EFAI RTSUITE CT HCAP-Segmentation System
The EFAI RTSUITE CT HCAP-Segmentation System does not offer a user interface and requires no user interaction, as explicitly stated in its device description. It outputs results for use in other programs or systems rather than having its own viewing graphical user interface.
2025-05
parikhradiology.com
EFAI RTSUITE CT HCAP-Segmentation System is a FDA-cleared radiology AI listing for Radiotherapy Planning Imaging.
The EFAI RTSUITE CT HCAP-Segmentation System is an FDA-cleared AI solution for radiotherapy planning imaging, intended for use by radiation oncologists, medical physicists, dosimetrists, and other trained professionals.
unknown
healthcareaiops.com
The Healthcare AI Transparency Registry
The EFAI RTSUITE CT HCAP-Segmentation System, developed by Ever Fortune.Ai, Co., Ltd., received FDA clearance on September 25, 2023, under product code QKB, which pertains to radiological image processing software for radiation therapy.
2026-10
fda.report
EFAI RTSUITE CT HCAP-Segmentation System
The EFAI RTSUITE CT HCAP-Segmentation System from Ever Fortune.Ai, Co., Ltd. received its FDA clearance on September 25, 2023.
2023-09
fda.gov
Seg Pro V3 (RT-300) 510(k) Premarket Notification
The EFAI RTSUITE CT HCAP-Segmentation System (K231928) is listed as a predicate device for the Seg Pro V3 (RT-300) system, both classified as Radiological Image Processing Software For Radiation Therapy (Product Code QKB) and regulated under 21 CFR 892.2050. Both devices automatically process input image data and send results as DICOM-RT Structure Sets, and neither has a user interface.
2026-01
innolitics.com
EFAI RTSUITE CT HCAP-Segmentation System. K231928
The EFAI RTSUITE CT HCAP-Segmentation System, identified by K231928, is subject to regulatory classification and potential future announcements from the FDA.
unknown

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Frequently Asked Questions

The EFAI RTSUITE CT HCAP-Segmentation System is an AI-powered software designed to enhance radiation therapy workflows by automatically delineating organs-at-risk (OARs) on CT images. This automation aims to reduce the time-consuming manual contouring process, improve accuracy, and facilitate treatment planning for radiation oncologists, medical physicists, and dosimetrists.
The EFAI RTSUITE CT HCAP-Segmentation System has received FDA 510(k) clearance (K231928) as a radiological image processing software for radiation therapy. It is intended to be used by trained radiation oncology professionals in conjunction with a DICOM-compliant treatment planning system to review and edit the generated contours.
Yes, several AI-driven auto-segmentation systems exist, such as MVision AI, Varian Ethos, RayStation, TheraPanacea ART-Plan, Imbio Lung Suite, and GE HealthCare's Auto Segmentation. The EFAI RTSUITE CT HCAP-Segmentation System, particularly its successor Seg Pro V3, offers expanded coverage across head and neck, thorax, abdomen, and pelvis, and supports both CT and MR imaging. While many systems aim to reduce contouring time and improve consistency, a comprehensive evaluation would involve comparing specific performance metrics and features for various anatomical regions.
The EFAI RTSUITE CT HCAP-Segmentation System, like other auto-segmentation tools, is intended to assist professionals and not to be used as a standalone diagnostic device or for automatic lesion detection. While AI systems improve efficiency and accuracy, limitations can include challenges in contouring smaller, intricate structures, especially on CT rather than MRI, and varying performance across different vendors and anatomical regions.
The system is designed to integrate seamlessly into clinical workflows by receiving images in DICOM format and generating OAR contours, which are then stored in DICOM format and RTSTRUCT modality. These contours are intended to be used with a DICOM-compliant treatment planning system, allowing healthcare professionals to review, edit, and make manual corrections as needed.

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