Home / Clinical Decision Support & Reference / QOCA image Smart CXR Image Processing System

QOCA image Smart CXR Image Processing System

by Quanta Computer · Based in Taiwan → — AI-powered chest X-ray analysis for rapid pneumothorax triage.

Emergency Medicine Pulmonology Radiology

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Regulatory Status Disclosed

Overview

The QOCA image Smart CXR Image Processing System is an AI-powered software designed to enhance radiology workflow efficiency by automatically analyzing adult chest X-rays. Utilizing deep learning technology, it identifies suspected pneumothorax cases and integrates seamlessly with hospital Picture Archiving and Communication Systems (PACS). The system automatically analyzes DICOM files, marking suspected cases to alert radiologists for prioritized review. It functions as a triage aid, not a standalone diagnostic tool, and is intended to assist radiologists in prioritizing urgent cases. The web-based medical software supports multiple users simultaneously and employs a locked AI algorithm for analyzing posteroanterior (PA) or anteroposterior (AP) erect chest X-ray images. Performance validation studies have shown high accuracy, with an Area Under the Curve (AUC) around 97-98%, sensitivity greater than 91%, and specificity greater than 92%, with an average analysis time of 4.94 seconds.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI/deep learning technology for chest X-ray analysis
Identifies suspected pneumothorax cases
Integrates with hospital PACS
Automatically analyzes DICOM files
Prioritizes urgent cases for radiologists
Web-based medical software
Supports multiple users simultaneously
Locked AI algorithm
Analyzes PA or AP erect chest X-ray images
High accuracy (AUC 97-98%, sensitivity >91%, specificity >92%)
Rapid analysis time (average 4.94 seconds)

Use Cases

Triage aid for radiologists
Enhancing radiology workflow efficiency
Prioritizing review of urgent chest X-ray cases
Detecting suspected pneumothorax in adult patients

What Physicians Need to Know

Evidence Base

The system utilizes a locked AI/deep learning algorithm. Its performance was validated using independent datasets, including MIMIC (US) and a Taiwanese hospital. The training process involved splitting data into training, validation, and separate performance assessment datasets.

Clinical Validation Studies

Two pivotal studies were conducted on independent datasets. The system achieved an Area Under the Curve (AUC) of 97-98%, sensitivity greater than 91%, and specificity greater than 92%. It demonstrated comparable accuracy to its predicate device, HealthPNX (K190362). The average analysis time was 4.94 seconds.

Alert Fatigue Management

The system functions as a triage aid, integrating with PACS to notify radiologists of *suspected* pneumothorax cases for prioritized review. It makes a notation next to suspected cases on a viewer page, focusing on worklist prioritization rather than generating numerous detailed diagnostic alerts, which inherently helps mitigate alert fatigue. It does not highlight specific image anomalies.

Override Rate Data

Specific override rate data is not explicitly provided. However, as a triage aid and not a standalone diagnostic tool, radiologists are expected to review and make the final diagnosis, effectively confirming or 'overriding' the AI's suspicion.

Guideline Update Frequency

Information regarding the frequency of guideline updates is not specified. The core AI algorithm is described as 'locked'.

Clinical Workflow Integration

The system integrates with hospital Picture Archiving and Communication Systems (PACS) to automatically analyze DICOM files. It is a web-based medical software supporting multiple users simultaneously, providing features for cases sorting and image viewing to aid in worklist triage.

Decision Audit Trail

Specific details about a decision audit trail for this product are not explicitly mentioned in the provided information.

Physician Tip

Physicians should recognize the QOCA image Smart CXR Image Processing System as a valuable triage tool designed to prioritize suspected pneumothorax cases for review. It is not a standalone diagnostic system and does not replace the radiologist's comprehensive interpretation and final diagnosis. The system flags cases for attention but does not highlight specific anomalies within the image, requiring the physician to perform a full diagnostic review.

The system is designed for seamless integration with existing hospital PACS (Picture Archiving and Communication Systems). It automatically processes DICOM files pushed from PACS and presents suspected cases on a web-based viewer page, facilitating efficient worklist prioritization for radiologists.

At a glance

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Deployment Hybrid (Web Based With PACS Integration)

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Details

Category	Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing	Contact vendor for pricing
Deployment	Hybrid (Web-based with PACS integration)
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated The QOCA image Smart CXR Image Processing System received FDA 510(k) clearance (K221868) on January 27, 2023. It is classified as a Software as a Medical Device (SaMD) intended to identify suspected pneumothorax cases in adult chest X-ray images as a triage aid for radiologists.
Integrations
EHR	Not specified
Specialties	Emergency Medicine, Pulmonology, Radiology

What the Web Says

The QOCA image Smart CXR Image Processing System is a web-based medical device that utilizes artificial intelligence (AI) and deep learning to analyze chest X-ray images of adult patients, primarily to identify cases with suspected pneumothorax and aid in worklist triage. It integrates with Picture Archiving and Communication Systems (PACS) and provides features like case sorting and image viewing. The system has demonstrated high accuracy in identifying suspected pneumothorax, with an Area Under the Curve (AUC) of 97.8% in performance assessments.

Overall: Positive

Strengths

High diagnostic accuracy for suspected pneumothorax (AUC of 97.8%).
Aids in worklist triage by prioritizing cases with suspected pneumothorax.
Web-based and supports multiple users simultaneously.
Integrates with existing PACS systems.
Utilizes advanced AI/deep learning technology for image analysis.
Can improve the efficiency of radiology workflow.

Limitations

Results are not a substitute for a radiologist's diagnosis and cannot be used for standalone clinical decision-making.
Does not directly indicate specific portions or anomalies on the image.
May produce false positives due to factors like skin folds, chest tubes, or implants.
Potential for false negatives if lung areas are unclear.
Limited to analyzing chest X-ray images of adult patients (20 years and older).
Some AI systems for CXR can produce false positives that require explanation to other doctors and patients, potentially increasing workload.

Based on reviews from: accessdata.fda.gov, qoca.com, MDPI, FUTURE HEALTH, Reddit, PubMed, Capterra

Last updated: 2026-07-19

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Press & Coverage

RadAI Slice (via X-ray Interpreter)

QOCA image Smart CXR Image Processing System Receives FDA Clearance

The QOCA image Smart CXR Image Processing System, an AI-powered software by Quanta Computer, received FDA clearance on January 27, 2023. It is designed to analyze adult chest X-rays to identify suspected pneumothorax cases and integrate with hospital PACS to prioritize urgent cases for radiologists.

2023-01

Radiology AI Tools Directory

QOCA image Smart CXR Image Processing System listed in FDA-cleared Radiology AI Tools Directory

The QOCA image Smart CXR Image Processing System by Quanta Computer Inc. is listed as an FDA-cleared device for image analysis/processing for Chest/Lung using Radiotherapy planning imaging, with a decision date of January 27, 2023.

2023-01

Journal article (unknown specific journal, but related to pulmonary drug delivery)

Applications of AI/ML in accelerating the development of pulmonary drug delivery system

A review article on AI/ML applications in pulmonary drug delivery systems mentions the QOCA image Smart CXR Image Processing System (Quanta Computer Inc., K221868) as one of the FDA-approved AI/ML-based medical devices for respiratory disease detection and diagnostics, cleared on January 27, 2023.

2026-02

Orthogonal

SaMD Cleared by the FDA: The Ultimate Running List

The QOCA image Smart CXR Image Processing System is included in a comprehensive list of FDA-cleared Software as a Medical Devices (SaMD), noting its clearance date as January 27, 2023, for radiology applications.

2024-10

FDA.report

Radiological Computer-Assisted Prioritization Software For Lesions QFM - FDA.report

The QOCA image Smart CXR Image Processing System (K221868) by Quanta Computer, Inc. is listed under the product code QFM, indicating it is radiological computer-assisted prioritization software for lesions, cleared by the FDA on January 27, 2023.

2023-01

Innolitics

Definitive Guide to AI/ML SaMD Ground Truthing

This article discussing ground truthing for AI/ML SaMD references the QOCA image Smart CXR Image Processing System (K221868) by Quanta Computer Inc., noting that its dataset was 'truthed by three radiologists' as part of its regulatory submission.

2025-09

FDA

510(k) Premarket Notification for QOCA image Smart CXR Image Processing System

The official FDA 510(k) Premarket Notification details the clearance of the QOCA image Smart CXR Image Processing System by Quanta Computer, Inc., with the submission number K221868 and a decision date of January 27, 2023.

2023-01

HaRi

QUANTA COMPUTER INC. - HaRi (Regulatory Registrations)

HaRi, a platform for regulatory intelligence, lists the QOCA image Smart CXR Image Processing System among Quanta Computer Inc.'s registered medical devices.

unknown

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Frequently Asked Questions

How does the QOCA image Smart CXR Image Processing System integrate into a radiologist's workflow and what is its primary clinical function?

The QOCA image Smart CXR Image Processing System integrates with hospital Picture Archiving and Communication Systems (PACS) to automatically analyze adult chest X-ray images. Its primary function is to identify suspected pneumothorax cases, acting as a triage aid to help radiologists prioritize urgent cases for review.

What regulatory clearances does the QOCA image Smart CXR Image Processing System hold for clinical use?

The QOCA image Smart CXR Image Processing System is classified as a Software as Medical Device (SaMD) and received FDA clearance (K221868) on January 27, 2023. It is designed to comply with quality systems regulations, such as 21 CFR Part 820.

What are the main limitations of the QOCA image Smart CXR Image Processing System, and can it be used for definitive diagnosis?

This system is intended solely as a triage tool and not as a standalone diagnostic device. Its results cannot substitute for a radiologist's diagnosis or be used for independent clinical decision-making. The system identifies suspected cases but does not highlight specific image anomalies.

What are the reported performance metrics and accuracy of the QOCA image Smart CXR Image Processing System for pneumothorax detection?

In validation studies, the system achieved an Area Under the Curve (AUC) of approximately 97-98%, with sensitivity exceeding 91% and specificity above 92%. It processes images rapidly, with an average analysis time of 4.94 seconds, facilitating quick triage notifications.

How does the QOCA image Smart CXR system compare to other AI-powered CXR solutions or traditional methods for pneumothorax detection?

The QOCA image Smart CXR system is comparable to predicate devices like HealthPNX, which also aids in worklist triage for suspected pneumothorax using AI. While many AI CXR solutions exist, this system focuses specifically on pneumothorax triage to enhance workflow efficiency.

How does the QOCA image Smart CXR Image Processing System ensure patient data privacy and security?

Medical AI systems, including this one, typically integrate with PACS and are subject to stringent data privacy regulations like HIPAA to protect patient health information. While specific details for this product were not explicitly found, other QOCA healthcare solutions adhere to ISO27001 security standards for encrypted data transmission.

What is the typical pricing model for implementing the QOCA image Smart CXR Image Processing System?

Specific pricing for the QOCA image Smart CXR system is not publicly available. However, AI radiology solutions commonly offer various pricing structures, including subscription-based models, pay-per-use fees, or custom/tiered pricing tailored to a department's imaging volume and specific needs.