AVIEW Lung Nodule CAD

by Coreline Soft Co.  · Based in South Korea →Advancing Radiology with AI
Cardiology Pulmonology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

AVIEW Lung Nodule CAD is an AI-based Computer-Aided Detection (CAD) software developed by Coreline Soft Co. It is designed to assist radiologists in the detection and analysis of pulmonary nodules (with diameters between 3-20 mm) during the review of CT examinations of the chest, particularly for asymptomatic populations. The software acts as an adjunctive tool, providing information to alert radiologists to regions of interest that may otherwise be overlooked, and can be used as a second reader after the radiologist’s initial assessment.

Beyond nodule detection, AVIEW Lung Nodule CAD is part of the broader AVIEW platform, which offers comprehensive analysis for what Coreline Soft refers to as the ‘Big 3’ thoracic diseases: lung cancer (via nodule analysis), chronic obstructive pulmonary disease (COPD), and coronary artery calcification (CAC). It can simultaneously analyze these conditions from a single low-dose CT scan, providing quantitative results for emphysema and CAC scoring. The system aims to automate tedious manual tasks, reduce radiologist workload, and improve the efficiency and accuracy of lung cancer screening and other thoracic disease diagnoses.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based pulmonary nodule detection (3-20 mm) on CT scans
  • Nodule classification (solid, part-solid, non-solid)
  • 3D nodule size and volume quantification
  • Automatic report generation based on Lung-RADS classification
  • Nodule matching and volume doubling time (VDT) calculation for follow-up comparisons
  • Simultaneous analysis of lung nodules, emphysema, and coronary artery calcification (Big 3)
  • Quantitative emphysema analysis (e.g., Low Attenuation Area - LAA, emphysema index)
  • Coronary Artery Calcification (CAC) scoring (Agatston, volume, mass scores)
  • Integration with Picture Archiving and Communication Systems (PACS) and Radiological Information Systems (RIS)
  • Customizable operation settings for sensitivity or specificity

Use Cases

  • Lung cancer screening programs and early detection of pulmonary nodules
  • Quantitative analysis and monitoring of emphysema
  • Assessment and scoring of coronary artery calcification
  • Reducing radiologist workload and improving reading efficiency
  • Monitoring nodule growth and risk stratification over time
  • Supporting clinical decision-making for thoracic diseases

What Physicians Need to Know

Cardiac CT/MRI Analysis
AVIEW LCS+ performs automated analysis of chest CT images to detect and quantify coronary artery calcification (CAC) simultaneously with lung nodule and emphysema analysis from a single low-dose, non-enhanced, non-gated CT scan.
Coronary Artery Assessment
The system automatically identifies calcifications in coronary arteries and computes standard calcium scores, including Agatston, volume, and mass scores. It also provides segment-level analysis by segmenting major coronary arteries such as the Left Main (LM), Left Anterior Descending (LAD), Left Circumflex (LCX), and Right Coronary Artery (RCA).
AHA/ACC Guideline Alignment
While primarily classifying lung nodules according to Lung CT Screening Reporting and Data System (Lung-RADS) guidelines, the tool's provision of standard Agatston scores for CAC aligns with established cardiac risk assessment methodologies. It also adheres to consistent thoracic CT protocols and patient safety guidelines.
Real-Time Alert Capability
AVIEW Lung Nodule CAD provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that might otherwise be overlooked. It also automates the generation of comprehensive reports for lung cancer screening results, emphysema, and coronary artery calcification.
Physician Tip

AVIEW Lung Nodule CAD, particularly the AVIEW LCS+ platform, offers a valuable opportunity for opportunistic screening of coronary artery calcification (CAC) during routine low-dose chest CT scans for lung cancer screening. This can aid in early cardiovascular risk stratification without requiring additional dedicated cardiac imaging. Physicians should leverage the automated CAC scoring and detailed arterial segmentation for comprehensive patient assessment. The tool's ability to act as a 'second reader' for lung nodules can enhance detection sensitivity and reduce reading time, while its adherence to Lung-RADS and standard CAC scoring ensures consistent reporting.

AVIEW Lung Nodule CAD is designed for seamless integration into standard radiology workflows. It complies with DICOM standards, allowing linkage with Picture Archiving and Communication Systems (PACS). The system supports various DICOM output formats, including DICOM SC, Encapsulated PDF, Key Images, DICOM GSPS, DICOM SEG, and DICOM SR. It also features worklist integration and the ability to generate pre-populated reports, streamlining the reporting process. Deployment options include cloud-based, hybrid solutions, or local installation on dedicated hardware or virtualized environments.

Details

Category Cardiology AI, Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Not publicly disclosed
  • Pricing models for similar deep learning CAD systems often vary and may include per-case fees or one-time investments, with cost-saving potential depending on workload and regional factors
DeploymentCloud-based, Hybrid solution, Locally on dedicated hardware, Locally virtualized (virtual machine, Docker)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

AVIEW Lung Nodule CAD received FDA 510(k) clearance (K251203) on December 3, 2025, as a Computer-Aided Detection (CAD) software. It is intended to assist radiologists in the detection of pulmonary nodules (3-20 mm) during the review of CT examinations of the chest for asymptomatic populations, and may be used as a second reader.

Integrations
EHR Not specified
Specialties Cardiology, Pulmonology, Radiology

What the Web Says

AVIEW Lung Nodule CAD, developed by Coreline Soft, is an AI-powered computer-aided detection (CAD) software designed to assist radiologists in identifying and analyzing pulmonary nodules on CT scans. It aims to improve detection sensitivity, reduce reading time, and standardize reporting based on guidelines like Lung-RADS. While studies suggest it can enhance nodule detection and potentially reduce workload, some sources indicate that there isn't yet enough evidence to recommend it for routine clinical use outside of research, particularly for people with suspected lung cancer or for reasons unrelated to cancer suspicion.

Overall: Mixed

Strengths

  • Increased sensitivity in lung nodule detection, including small nodules.
  • Reduces radiologists' reading time and workload.
  • Provides 3D size, volume, and classification (solid, part-solid, non-solid) of nodules.
  • Automates Lung-RADS classification and generates structured reports.
  • Facilitates longitudinal tracking of nodules by comparing current and prior examinations.
  • FDA cleared and meets international security standards.

Limitations

  • Not enough evidence to recommend for routine clinical use outside of research for certain patient groups.
  • Potential for increased false positives, leading to unnecessary follow-up for benign nodules.
  • Some studies show AI-CAD systems can be inferior to radiologists as a primary reader for nodule detection.
  • Workload reduction and time-saving claims by the vendor could not always be independently validated.
  • Concerns about the quality of evidence in some systematic reviews regarding AI for lung nodule detection.
  • May require further optimization for seamless integration into existing radiology infrastructures.

Based on reviews from: NICE, Alma Medical Imaging, AuntMinnie, PMC (PubMed Central), accessdata.fda.gov, Thorax (journal), Radailogy, Coreline Soft (Press Release), Sectra Amplifier Marketplace, Journal of Thoracic Disease, AJR (American Journal of Roentgenology), Reddit, Rayscape AI

Last updated: 2026-07-21

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Press & Coverage

KBR
Coreline Soft's AI-backed lung nodule detector gets FDA 510(k) clearance - KBR
Coreline Soft's AVIEW Lung Nodule CAD, an AI-based lung nodule detection solution, received FDA 510(k) clearance, making it the first AI-based lung nodule detection CAD in Korea and the fifth globally to obtain this approval. Clinical trials showed that the CAD increased nodule detection sensitivity by 34%, decreased false positives by 42%, and reduced reading time by 70%.
2023-03
Coreline Soft
Coreline Soft Secures US FDA Clearance Renewal for 'AI Lung Nodule CAD'
Coreline Soft announced the renewal of its FDA 510(k) clearance for 'AVIEW Lung Nodule CAD', meeting strengthened cybersecurity review criteria. The solution has processed over 2.5 million clinical data cases across 19 countries and is used in European government-led lung cancer screening projects.
2025-12
AuntMinnie
Lung cancer screening software approved in South Korea | AuntMinnie
Coreline Soft received approval from the South Korea Ministry of Food and Drug Safety for its AVIEW Lung Nodule CAD software, which uses AI to identify pulmonary nodules on CT scans. The software achieved a 97% nodule detection rate in a clinical trial and is being prepared for submission for approval in the U.S. and European Union.
2020-07
Innolitics (FDA 510(k) database)
AVIEW Lung Nodule CAD (K221592) u2014 FDA 510(k) | Innolitics
The FDA 510(k) premarket notification for AVIEW Lung Nodule CAD details its intended use as a computer-aided detection (CAD) software to assist radiologists in detecting pulmonary nodules (3-20 mm) on chest CT scans for asymptomatic populations. It is designed to be used as a second reader after the radiologist's initial review.
2023-02
PMC (PubMed Central)
Artificial intelligence system for identification of overlooked lung metastasis in abdominopelvic computed tomography scans of patients with malignancy - PMC
A study evaluated the AVIEW Lung Nodule CAD system for identifying overlooked lung metastases in abdominopelvic CT scans of cancer patients. The AI model, originally optimized for low-dose chest CT, was used to detect pulmonary nodules in basal lungs.
2025-07
BioWorld
Coreline Soft wins FDA approval, raises u20a918B in private placement | BioWorld
Coreline Soft has secured nine FDA approvals, including for AVIEW Lung Nodule CAD in 2023, and has also raised u20a918 billion in private placement. The company's Aview product line, including Aview LCS (lung cancer screening solution), has been consistently gaining regulatory clearances.
2024-04
KBR
Coreline Soft to showcase AI solutions at NASCI 2024, accelerating US entry - KBR
Coreline Soft's AVIEW Lung Nodule CAD received U.S. FDA certification in 2023, making it the first Korean product and fifth globally to achieve this for an AI-based lung nodule detection solution. The company is expanding its presence in the US market through partnerships and showcasing its AI solutions at conferences.
2024-09
AJR Online
Opportunistic Screening on Chest CT, From the AJR Special Series on Screening - AJR Online
AVIEW Lung Nodule CAD from Coreline Soft is listed as an FDA-cleared device for lung nodule detection in a review on opportunistic screening on chest CT. The article highlights the increasing number of chest CT examinations and the opportunity for radiologists to assess imaging biomarkers for various health aspects.
2025-07

Videos

Product demos, reviews, and walkthroughs for AVIEW Lung Nodule CAD.

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Frequently Asked Questions

AVIEW Lung Nodule CAD integrates with Picture Archiving and Communication Systems (PACS) by complying with DICOM standards, allowing for seamless linking and data exchange. It functions as a 'second reader' to assist radiologists after their initial review, providing a separate user interface for analyzing, identifying, storing, and transmitting quantified nodule values.
AVIEW Lung Nodule CAD has received 510(k) clearance renewal from the US FDA, meeting stringent cybersecurity requirements including security lifecycle management, SBOM submission, encryption, and access control. It also holds CE Mark (Class IIb) and Health Canada approval. Coreline Soft, the developer, has achieved compliance with HIPAA and GDPR, ensuring robust patient data privacy and security.
AVIEW Lung Nodule CAD distinguishes itself by its ability to simultaneously analyze lung nodules, emphysema, and coronary artery calcification from a single low-dose CT scan. This comprehensive analysis provides a broader health assessment beyond just nodule detection, which can be an advantage over systems focused solely on lung nodules like AI-Rad Companion Chest CT or ClearRead CT.
While specific pricing for AVIEW Lung Nodule CAD is not publicly detailed, AI-powered CAD systems generally offer various pricing models, including pay-per-use, yearly subscriptions, or one-off perpetual software licenses. Cost-effectiveness studies suggest that for these systems to reach a break-even point, pay-per-case models often need to be priced below a certain threshold or utilized in high-volume clinical settings.
AVIEW Lung Nodule CAD has demonstrated a 42% decrease in false positives and a 34% increase in nodule detection sensitivity in clinical trials. However, like all CAD systems, it can still produce false positives, which radiologists must review and filter. The algorithm was primarily validated on non-contrast CT images from Siemens SOMATOM CT series scanners, suggesting a recommended limitation of use to these systems.
Clinical trials have shown AVIEW Lung Nodule CAD to improve lung nodule detection sensitivity by 34% and reduce false positives by 42%, leading to a 70% decrease in reading time. The system's stability and efficacy have been verified through processing over 2.5 million clinical data cases across 19 countries. It has also been adopted in major government-led lung cancer screening projects in Europe and Korea, such as HANSE, IMPULSION, RISP, and K-LUCAS.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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