qXR-LN

by Qure.ai Technologies  · Based in India →AI assistance for Accelerated Healthcare
Emergency Medicine Pulmonology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

qXR-LN by Qure.ai is a cutting-edge computer-aided detection (CAD) software designed to identify and highlight regions indicative of suspected pulmonary nodules, ranging from 6 to 30 mm in size, on frontal chest X-rays of adults. This AI tool acts as a secondary reader, assisting physicians such as radiologists, pulmonologists, and emergency room physicians in the review of chest X-rays, particularly for the incidental detection of lung nodules. It is not intended to be used on a standalone basis for clinical decision-making or to rule out target conditions, but rather to complement the expertise of medical professionals by providing adjunctive information. qXR-LN integrates seamlessly into existing standard of care workflows, offering pre-read assistance and serving as a passive notification system for worklist prioritization, ultimately aiming to support earlier identification of lung cancers and improve patient outcomes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered detection and localization of lung nodules (6-30mm) on chest X-rays
  • Acts as a secondary reader to aid physicians
  • Provides pre-read assistance within seconds
  • Identifies incidental findings for lung cancer
  • Integrates into existing standard of care workflow for worklist prioritization
  • Can be deployed on cloud or on-premise
  • Offers multilingual support on mobile and web (for qXR platform)
  • Produces DICOM format outputs
  • Compatible with any DICOM viewer or PACS
  • Clinically validated in multiple geographies

Use Cases

  • Early detection of lung cancer
  • Screening for pulmonary nodules on chest X-rays
  • Assisting radiologists in reviewing chest X-rays
  • Aiding pulmonologists and ER physicians in nodule detection
  • Workflow triage by flagging suspected findings
  • Reducing time to diagnosis in critical settings

What Physicians Need to Know

Key Capabilities
qXR-LN is computer-aided detection software designed to identify and mark suspected pulmonary nodules ranging from 6 to 30 mm in size on frontal (AP/PA) chest radiographs. It acts as a second reader, utilizing a deep learning algorithm to detect subtle nodules with high accuracy.
Clinical Utility
Intended for use in the incidental adult population, qXR-LN aids radiologists, pulmonologists, and ER physicians in early detection of potentially malignant pulmonary nodules, thereby supporting the fight against lung cancer. It can improve diagnostic accuracy and help prioritize patients for follow-up CT scans.
Integration Options
The software is compatible with any DICOM viewer or PACS, receiving and producing images in DICOM format. It can be deployed on cloud or on-premise and integrates into existing standard workflows as a passive notification system for worklist prioritization. Qure.ai products also integrate with various AI platforms.
Compliance Status
qXR-LN has received FDA 510(k) Class II clearance for enhanced lung nodule detection, making it the only FDA-cleared solution for this purpose with radiologists, pulmonologists, and ER physicians as intended users. It is also subject to Quality System (QS) regulation (21 CFR Part 820).
Pricing Model
The general qXR product suite operates on a subscription model, with pricing typically based on the number of analyses or installations. Reimbursement for AI-enabled lung cancer pathways is evolving, with Qure.ai products potentially billable under CMS-issued CPT codes.
User Experience
Designed to provide pre-read assistance within 20 seconds, qXR-LN augments productivity with pre-filled reports and AI overlays. Multi-reader, multi-case studies have shown improved lung nodule detection performance for aided readers, with some non-radiologist physicians achieving or surpassing baseline radiologist performance. It also offers multilingual support.
Implementation Complexity
The solution can be deployed flexibly on cloud or on-premise and is designed for seamless integration into existing standard workflows, with Qure.ai claiming '0% effort in integration' for its broader qXR product. It supports radiology workflow orchestration and automates longitudinal tracking.
Evidence Base
qXR-LN was trained on a diverse dataset of 2.5 million scans. Pivotal studies demonstrated a nodule-level sensitivity of 84.1% and a scan-level AUC of 94.51%. Multi-reader, multi-case studies confirmed statistically significant improvement in nodule detection. Other qXR studies show high sensitivity (99.7%) and negative predictive value (98.9%-99.43%) for abnormality detection, with some studies showing superior sensitivity to radiologists in detecting malignant nodules.
Physician Tip

qXR-LN serves as a valuable 'second pair of eyes' for detecting pulmonary nodules on chest X-rays, particularly for incidental findings. While it significantly enhances detection accuracy and can reduce workload by prioritizing cases, it is crucial to remember that it is an aid and not a substitute for comprehensive physician review and clinical judgment. Integrate its findings with other patient information for optimal decision-making, especially for follow-up recommendations. The tool's ability to detect smaller nodules (6-10mm) can be particularly beneficial in early lung cancer detection programs.

qXR-LN is designed for straightforward integration into existing radiology workflows, leveraging DICOM for image input and output, and compatibility with standard PACS and DICOM viewers. Its deployability on both cloud and on-premise offers flexibility. For broader enterprise integration, Qure.ai's ecosystem supports various major AI platforms, facilitating a unified approach to AI-powered diagnostics within a healthcare system.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud, On-premise
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

qXR-LN received FDA 510(k) clearance (K231805) on December 22, 2023, as a Class II medical device (Medical Image Analyzer, Product Code MYN). It is intended as computer-aided detection software to identify and mark regions indicative of suspected pulmonary nodules (6 to 30 mm) on frontal chest X-rays of adults, to be used as a second reader to aid physicians.

Integrations
EHR Not specified
Specialties Emergency Medicine, Pulmonology, Radiology

What the Web Says

Qure.ai's qXR-LN is an AI-powered software designed to detect and localize lung nodules (6-30mm) on chest X-rays, primarily for incidental adult populations. It has received FDA clearance and is intended to serve as a crucial second reader for physicians, including radiologists, pulmonologists, and emergency room physicians. Studies have shown that qXR-LN significantly enhances pulmonary nodule detection, with some emergency room physicians and pulmonologists achieving or surpassing the baseline performance of unaided radiologists when using the tool.

Overall: Positive

Strengths

  • Enhanced pulmonary nodule detection across various reader groups, including radiologists, pulmonologists, and emergency room physicians.
  • Can help detect subtle anatomical anomalies that might otherwise go unnoticed, especially in asymptomatic patients.
  • Achieved an impressive Area Under the Curve (AUC) of 94% for nodule detection in standalone performance studies.
  • Demonstrated a high negative predictive value of 96% and an AUC of 0.99 for detection of pulmonary nodules in a retrospective study.
  • Aids in early-stage lung cancer detection, which is crucial for improving patient outcomes.
  • Integrates into existing radiology workflows and can be deployed on cloud or on-premise.

Limitations

  • No specific cons for qXR-LN were found in the provided search results.
  • General Qure.ai feedback mentions that support and guidance to doctors about usability could be improved.

Based on reviews from: Qure.ai, Diagnostic Imaging, The Imaging Wire, TestDynamics, G2

Last updated: 2026-07-18

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Press & Coverage

Imaging Technology News
Qure.ai Nets FDA Clearance for AI-Powered Chest X-ray Lung Nodule Solution
Qure.ai received FDA clearance for its qXR-LN, an AI-powered chest X-ray solution that identifies and localizes lung nodules, marking its sixth FDA clearance for chest X-ray-based solutions.
2024-01
Qure.ai Press Release
Qure's Chest X-ray AI gets FDA nod for lung nodule detection
Qure.ai announced its 13th FDA clearance for AI-enabled solutions, specifically for its qXR-LN, which uses AI to identify and localize lung nodules on chest X-rays.
2024-01
Qure.ai
FDA-cleared chest x-ray AI shows great promise in missed lung cancer detection - Qure.ai
A new study presented at the American Roentgen Ray Society's (ARRS) 2026 annual meeting highlighted the potential of Qure.ai's FDA-cleared qXR-LN to identify lung cancers initially missed on routine chest X-rays.
2026-04
AuntMinnie.com
Qure.ai gets FDA nod for chest x-ray software - AuntMinnie
Qure.ai received FDA clearance for its qXR-LN computer-aided detection chest X-ray software, designed to identify lung nodules between 6 mm and 30 mm.
2024-01
Qure.ai
Future of AI-powered incidental pulmonary nodule detection - Qure.ai
Qure.ai's qXR-LN chest X-ray AI algorithm demonstrates high accuracy in detecting incidental pulmonary nodules, with a negative predictive value of 96% and an AUC of 0.99 in a retrospective study.
2025-02
Qure.ai Press Release
Qure.ai Launches FDA-Cleared AI To Quantify Lung Nodules
Qure.ai announced FDA clearance for its qCT LN Quant, an AI-powered chest CT solution for advanced lung nodule quantification, which complements qXR-LN for early detection.
2024-08
Qure.ai Press Release
Qure.ai partners Strategic Radiology for AI-Powered Imaging
Qure.ai partnered with Strategic Radiology to integrate its AI algorithms, including the FDA-cleared qXR-LN, into radiology workflows to support diagnostic decision-making.
2024-06
Qure.ai
Evaluation of an Artificial Intelligence Defined Lung Nodule Malignancy Score (qXR-LNMS) in Incidental Pulmonary Nodules: The CREATE Study - Qure.ai
The CREATE study evaluated Qure.ai's qXR-LNMS, an AI-based tool designed to assess the malignancy likelihood of lung nodules detected on chest X-rays, showing its potential for earlier and more accurate risk stratification.
2026-01

Videos

Product demos, reviews, and walkthroughs for qXR-LN.

View all on YouTube

Frequently Asked Questions

qXR-LN is designed to function as a crucial 'second reader' for physicians, including radiologists, pulmonologists, and emergency room physicians, assisting in the review of frontal chest radiographs acquired on digital radiographic systems. It automatically analyzes images to identify and highlight regions indicative of suspected pulmonary nodules, providing adjunctive information to aid the physician's assessment.
qXR-LN has received 510(k) clearance from the U.S. FDA, indicating its safety and efficacy as a medical device. Qure.ai, the developer, states a commitment to healthcare information security and adherence to global medical device regulations, including ISO 13485 standards. While specific HIPAA compliance details aren't explicitly detailed in the search results, FDA-cleared medical devices typically operate within frameworks that necessitate patient data protection.
qXR-LN is designed to detect and highlight suspected pulmonary nodules ranging from 6 to 30 mm in size. It provides adjunctive information only and is not intended to be used on a standalone basis for clinical decision-making, nor is it a substitute for the original chest radiographic image or intended to rule out target conditions.
While qXR-LN is noted as the only FDA-cleared solution for detecting and localizing lung nodules using computer vision with radiologists, pulmonologists, and ER physicians as intended users, other AI solutions for chest X-ray interpretation support exist. These include Lunit INSIGHT CXR, Aidoc, Annalise.ai, and other offerings from companies like Google Health, which provide various functionalities for abnormality detection and triage.
The provided search results do not contain specific details regarding the pricing or licensing models for qXR-LN. Information on pricing structures would typically be obtained directly from Qure.ai or through their sales representatives. However, AI solutions like qXR-LN are generally offered through licensing agreements or subscription models for healthcare facilities.
In pivotal studies, qXR-LN demonstrated a standalone performance with an Area Under the Curve (AUC) of 94% for nodule detection. Multi-reader studies showed that its use led to a statistically significant and clinically meaningful enhancement in pulmonary nodule detection across various reader groups, with some emergency room physicians and pulmonologists approaching or surpassing the baseline performance of radiologists.
qXR-LN can improve patient outcomes by enhancing the early detection of potentially malignant pulmonary nodules, enabling timely interventions and improving survival rates for lung cancer. For workflow efficiency, it acts as a 'second pair of eyes,' helping to identify subtle anomalies that might otherwise be missed and potentially aiding in prioritizing cases for review.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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