EFAI ChestSuite XR Pleural Effusion Assessment System

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

Contact for pricing
Regulatory Status Disclosed

Overview

Ever Fortune.AI Co., Ltd. is a technology company specializing in artificial intelligence solutions for the healthcare sector, leveraging advanced AI and big data analysis to improve patient outcomes and assist in diagnostics and disease prediction. The company is committed to innovative developments in artificial intelligence, smart medicine, and precision medicine as a pioneer of digital healthcare.

The EFAI ChestSuite XR Pleural Effusion Assessment System is a radiological computer-assisted triage and notification software system. It utilizes deep learning techniques to automatically analyze PA chest X-rays, identifying suspected findings of pleural effusion. The system then sends notification messages to the Picture Archiving and Communication System (PACS) or Radiology Information System (RIS), enabling worklist prioritization and triage for medical specialists. It is designed to enhance clinical workflow efficiency and is not intended for stand-alone clinical decision-making.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Radiological computer-assisted triage and notification software
  • Utilizes deep learning techniques for automated analysis of PA chest X-rays
  • Identifies suspected pleural effusion findings
  • Sends notification messages to PACS/RIS for worklist prioritization
  • High sensitivity (95%) and specificity (97%) for pleural effusion detection
  • Average performance time of 19.6 seconds
  • Not intended for stand-alone clinical decision-making
  • Part of ChestSuite XR Assessment System, which also assesses pneumothorax, cardiothoracic ratio, and endotracheal tube depth

Use Cases

  • Workflow triage in hospital networks
  • Assisting medical specialists in prioritizing chest X-ray cases with suspected pleural effusion
  • Improving image interpretation efficiency for physicians
  • Shifting radiology focus from volume to value by identifying high-confidence no-findings X-rays
  • Applicable in hospitals, health examination centers, and mobile health clinics

What Physicians Need to Know

DICOM Support & Standards
The system supports DICOM for image input, processing, storing, and transferring data, ensuring compatibility with existing medical imaging infrastructure.
PACS Integration Method
It integrates seamlessly with PACS/RIS workstations, sending notification messages and key images to allow suspicious findings of pleural effusion to be identified and for worklist prioritization or triage.
Reading Room Workflow Impact
Functions as a computer-assisted triage and notification software, designed to improve image interpretation efficiency, assist physicians in quicker interpretation, and shift radiology focus from volume to value by highlighting cases with pathologies. It proactively sends alerts to enable more rapid response than conventional workflows.
AI Model Architecture (deep learning approach)
The software utilizes deep learning techniques and algorithms to automatically analyze chest X-ray images.
Processing Speed (per study)
The average performance time for the EFAI ChestSuite XR Pleural Effusion Assessment System is 19.6 seconds per study.
FDA Clearance Pathway
Cleared through the Traditional 510(k) pathway by the U.S. FDA (K222076).
Supported Modalities
Primarily supports X-ray (PA view) for chest imaging.
Sensitivity & Specificity Data
In a standalone performance test, the system demonstrated a sensitivity of 0.9510 (95% CI=0.9195-0.9706) and a specificity of 0.9745 (95% CI=0.9505-0.9870) for assessing pleural effusion, with an AUC of 0.9712 (95% CI=0.9538-0.9885).
RSNA/ACR Validation
Performance was evaluated and verified through internal validation and standalone performance tests, adhering to software specifications, applicable performance standards, and FDA Guidance documents, including IEC 62304:2006/A1:2016.
Physician Tip

Leverage the EFAI ChestSuite XR Pleural Effusion Assessment System for efficient triage and prioritization of chest X-rays, especially in high-volume settings. The system's rapid processing speed and high sensitivity/specificity for pleural effusion can aid in quickly identifying critical cases, allowing radiologists to focus on complex interpretations. Remember that it functions as a computer-aided triage and notification tool, and its results are not intended for standalone clinical decision-making.

The system is designed for seamless integration with existing PACS/RIS workstations via DICOM, enabling automated image analysis and the proactive sending of alerts for suspected findings. Deployment is recommended within a local network with existing hospital-grade IT systems, installed on a specialized server supporting deep learning processing.

Details

Category Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentLocal network with an existing hospital-grade IT system; installed on a specialized server supporting deep learning processing.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The EFAI ChestSuite XR Pleural Effusion Assessment System received U.S. FDA 510(k) clearance (K222076) on September 8, 2022, as a radiological computer-assisted triage and notification software for lesions.

Integrations
EHR Not specified
Specialties Emergency Medicine, Pulmonology, Radiology

What the Web Says

The EFAI ChestSuite XR Pleural Effusion Assessment System is an AI-powered software designed to analyze PA chest X-rays for suspicious findings of pleural effusion, aiming to aid in the prioritization and triage of radiological medical images. It uses deep learning techniques to identify potential pleural effusions and sends notifications to PACS/workstations, helping radiologists and emergency physicians accelerate image review workflows and potentially reduce missed diagnoses. The system has received FDA clearance and demonstrated high sensitivity and specificity in detecting pleural effusion.

Overall: Positive

Strengths

  • High sensitivity (95%) and specificity (97%) for detecting pleural effusion.
  • Aids in worklist prioritization and triage of chest X-ray cases, potentially speeding up diagnosis for urgent cases.
  • Uses deep learning techniques for automated analysis of PA chest X-rays.
  • Comparable performance time to predicate devices.
  • Consistent performance across various subgroups including gender, data source, scanner manufacturers, size, and location of pleural effusion.
  • Integrates into existing PACS/workstation workflows.

Limitations

  • Not intended for stand-alone clinical decision-making or to rule out pleural effusion.
  • Performance may be reduced for small, trace, or complex effusions and in critically ill patients, based on a systematic review of AI-assisted TUS for PE detection.
  • AI tools, in general, can produce more false-positive results than radiologists, and their performance may decrease with multiple findings or smaller targets.
  • Limited information available from independent tech reviewers, G2, Capterra, or extensive Reddit discussions specifically about this product.
  • Overall certainty of AI-assisted TUS for PE detection is low-to-moderate due to methodological weaknesses in studies.
  • Requires installation on a specialized server supporting deep learning processing within a hospital-grade IT system.

Based on reviews from: accessdata.fda.gov, EverFortune.AI, X-ray Interpreter, Diagnostic Imaging, MDPI, PubMed, AuntMinnie, Radiology (RSNA), Imaging Technology News, Muriel Steele Society, Applied Radiology, Reddit, Thoracic Research and Practice

Last updated: 2026-07-18

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Press & Coverage

FDA
EFAI ChestSuite XR Pleural Effusion Assessment System - 510(k) Premarket Notification
This FDA 510(k) premarket notification details the EFAI ChestSuite XR Pleural Effusion Assessment System, submitted by Ever Fortune.AI, Co., Ltd. in September 2022. It outlines the device's intended use as a radiological computer-assisted triage and notification software system that uses deep learning to analyze chest X-rays for pleural effusion.
2022-09
accessdata.fda.gov
EFAI ChestSuite XR Pleural Effusion Assessment System - FDA 510(k) Summary
This document provides a summary of the EFAI ChestSuite XR Pleural Effusion Assessment System, describing it as a radiological computer-assisted triage and notification software that uses deep learning to analyze PA chest X-rays for suspicious findings of pleural effusion. The system aims to aid in prioritization and triage of radiological medical images.
2022-07
Healthcare+ B2B
Ever Fortune AI Technology's AI-Powered Endotracheal Tube Depth Detection System Secures FDA Clearance
Ever Fortune AI Technology announced FDA clearance for its Endotracheal Tube Depth Detection System (EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM), which uses AI to analyze chest X-rays for endotracheal tube malposition. The system sends alerts to PACS/RIS workstations to enable faster identification and response, enhancing patient safety.
2025-02
accessdata.fda.gov
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) - FDA 510(k) Premarket Notification
This FDA document details the 510(k) premarket notification for the EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM, a radiological computer-aided triage and notification software. It uses deep learning to analyze chest radiographs and flag suspected cases of vertically malpositioned endotracheal tubes.
2025-02
EverFortune.AI
ChestSuiteuff5cEverFortune.AI
Everfortune.AI's ChestSuite, which includes assessment for pleural effusion, has received TFDA approval and FDA clearance. This AI-powered system automatically identifies pneumothorax, pleural effusion, cardiothoracic ratio abnormality, and endotracheal tube malposition to accelerate image review and reduce missed diagnoses.
unknown
PMC
Automated Computer-Assisted Diagnosis of Pleural Effusion in Chest X-Rays via Deep Learning
This study proposes an automated pleural effusion detection system for CXR images, integrating image cropping, enhancement, and the EfficientNet-B0 deep learning model. The system achieved an accuracy of 93.27%, significantly improving upon previous studies and aiming to reduce manual interpretation workload.
2025-09
Diagnostic Imaging
FDA Clears Ultrasound AI Detection for Pleural Effusion and Consolidation
The FDA granted 510(k) clearance for ultrasound-based AI software by Exo to detect pleural effusion and consolidation/atelectasis, available on the Exo Iris handheld ultrasound device. This AI provides automated detection of pulmonary markers, enabling clinicians to recognize lung diseases like pneumonia and tuberculosis in seconds.
2025-06
AZmed
AZmed Receives Two New FDA Clearances for Its AI-Powered Chest X-ray Solution
AZmed announced two new FDA clearances for its AI tool AZchest, which assists radiologists in interpreting chest X-rays for lung nodules and triaging pneumothorax and pleural effusion. The software demonstrated high sensitivity and AUC for both pneumothorax and pleural effusion.
2025-04

Videos

Product demos, reviews, and walkthroughs for EFAI ChestSuite XR Pleural Effusion Assessment System.

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Frequently Asked Questions

EFAI ChestSuite XR is designed as a radiological computer-assisted triage and notification software system that uses deep learning to analyze PA chest X-rays. It integrates with standard PACS/RIS systems by sending notification messages and case-level output for worklist prioritization, aiming to minimize disruption and enhance efficiency.
Physicians can expect enhanced detection sensitivity and specificity for pleural effusions, with reported sensitivities around 95% and specificities around 97%. The system aims to aid in the clinical assessment of adult chest X-ray cases with features suggestive of pleural effusion, potentially leading to earlier diagnosis and more consistent reporting.
EFAI ChestSuite XR has received FDA 510(k) clearance, indicating it is substantially equivalent to predicate devices in terms of safety and effectiveness. Its clinical claims are supported by performance data demonstrating high sensitivity and specificity in detecting pleural effusions, validated through clinical and nonclinical tests.
While specific details on HIPAA/GDPR compliance are not explicitly stated in the provided search results, medical AI systems like EFAI ChestSuite XR are generally designed with robust data security protocols, including encryption and anonymization, to protect patient health information and adhere to relevant privacy regulations. The system processes DICOM images, and data transfer and preprocessing are key stages in its operation.
EFAI ChestSuite XR focuses specifically on pleural effusion assessment, providing an AI-driven second read to augment, rather than replace, traditional interpretation. It offers high accuracy and rapid processing times, aiming to improve image interpretation efficiency and assist physicians in prioritizing cases. Other AI tools may focus on broader chest X-ray findings or different modalities like ultrasound.
Like other AI tools, EFAI ChestSuite XR is a decision support tool and not intended for stand-alone clinical decision-making. Studies on similar AI systems suggest potential limitations with small or subtle effusions, atypical presentations, or when multiple findings are present on a single X-ray, where sensitivity may decrease and false positives may increase compared to radiologist assessment.
The provided search results do not contain specific pricing information for EFAI ChestSuite XR. Generally, AI software pricing models in healthcare can vary, often involving subscription-based licenses per study, per user, or site-wide annual fees, with costs influenced by factors such as usage volume, integration complexity, and included support services.

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