Rayvolve LN
Contact for pricing
Regulatory Status Disclosed
Overview
Rayvolve LN by AZmed is a computer-aided detection (CAD) software designed to assist radiologists in identifying and marking suspected pulmonary nodules on chest X-rays. It is intended for use with frontal (AP/PA) chest radiographs of adult patients (18 years of age or older) and focuses on nodules ranging from 6 to 30mm in size.
- For: Radiologists and emergency physicians in various care settings, including hospitals and imaging centers.
- Workflow Integration: Rayvolve LN integrates into existing clinical workflows, connecting with PACS/RIS environments. It functions as a second reader, providing adjunctive information by generating a duplicate image with annotations or a DICOM Structured Report, without modifying the original DICOM object or blocking the modality worklist.
- Notable Capabilities: The tool utilizes deep learning techniques to detect and localize pulmonary nodules. It is part of the broader Rayvolve AI Suite, which also includes modules for fracture detection (AZtrauma), chest pathologies (AZchest), orthopedic measurements (AZmeasure), and bone age estimation (AZboneage). Rayvolve LN is designed to support diagnostic accuracy and potentially streamline workflow by highlighting areas of interest.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Computer-aided detection (CADe) for pulmonary nodules
- Identifies and marks suspected pulmonary nodules (6-30mm)
- Assists radiologists as a second reader
- Analyzes frontal (AP/PA) chest radiographs
- Utilizes deep learning techniques
- DICOM compatibility for input and output
- Integrates with existing DICOM Node servers (e.g., PACS)
- Aids in reviewing chest radiographs for patients 18 years or older
- Aims to increase workflow efficiency
- Aims to improve diagnostic precision
Use Cases
- Detection of pulmonary nodules on chest X-rays
- Assisting radiologists in reviewing frontal chest radiographs
- Improving diagnostic consistency for pulmonary nodule detection
- Streamlining radiology workflow for chest imaging
- Reducing diagnostic risk in chest radiography
What Physicians Need to Know
Key Capabilities
Rayvolve LN is a computer-aided detection (CAD) software designed to assist radiologists in identifying and marking suspected pulmonary nodules on frontal (AP/PA) chest radiographs. It targets nodules between 6 and 30mm in size in patients 18 years or older, acting as a 'second reader' using deep learning techniques.
Clinical Utility
This tool aims to enhance diagnostic accuracy by aiding in the detection of pulmonary nodules, potentially reducing missed abnormalities and the need for repeat examinations. It supports faster diagnosis and can help standardize reporting across radiologists, ultimately contributing to reduced radiologist fatigue and improved patient care.
Integration Options
Rayvolve LN offers seamless, 'plug-and-play' integration into existing PACS/RIS workflows, utilizing the DICOM image standard. It can interact with DICOM Node servers and clinical-grade image viewers, delivering results and visual indicators directly into the radiologist's worklist without requiring additional clicks or platform switching. Deployment options include on-premise, cloud, or hybrid models.
Compliance Status
Rayvolve LN is a Medical Device Class IIa in Europe (CE 2797), compliant with the Medical Device Regulation (2017/745). In the US, it holds Medical Device Class II status, with 510(k) clearances (e.g., K243831).
Pricing Model
Pricing models for AZmed's Rayvolve AI Suite, which includes Rayvolve LN, vary and can include per-study fees, annual licenses, or value-based contracts tied to clinical Key Performance Indicators (KPIs).
User Experience
Designed for non-invasive usability, Rayvolve LN integrates into radiologists' existing systems to avoid 'AI fatigue' and minimize changes to work habits. It presents results and visual indicators directly within the DICOM viewer, aiming for seamless adoption without slowing down workflows.
Support Quality
While specific details on 'Support Quality' are not explicitly provided, AZmed emphasizes clinical validation and widespread deployment across over 2,500 healthcare facilities globally, implying robust operational support and ongoing reliability.
Implementation Complexity
Described as 'plug-and-play,' Rayvolve LN aims for low implementation complexity with seamless integration into PACS/RIS. It offers flexible deployment options (on-premise, cloud, hybrid) to align with IT infrastructure and data governance requirements, mitigating perceived stress during adoption.
Evidence Base
Rayvolve LN is clinically validated, with a standalone performance assessment showing sensitivity of 0.8847, specificity of 0.8294, and an AUC of 0.8408 for nodule detection. Studies demonstrate consistent performance improvement in AI-aided reads, with reader AUC increasing. The broader Rayvolve AI Suite is backed by over 30 studies and 10+ peer-reviewed publications, having analyzed over 15 million X-rays.
Physician Tip
Rayvolve LN serves as an invaluable 'second reader' for chest X-rays, specifically for pulmonary nodule detection (6-30mm). It's designed to augment, not replace, your clinical judgment. Leverage its seamless integration into your PACS/RIS to enhance diagnostic confidence and efficiency, particularly in high-volume settings or for subtle findings. Remember to always review the original images and integrate the AI's findings into your comprehensive assessment. Its ability to standardize reporting and potentially reduce turnaround times can significantly impact workflow and patient care.
Rayvolve LN is built for seamless integration into existing radiology workflows. Its DICOM compliance ensures compatibility with most PACS and RIS systems, allowing for direct delivery of AI-generated annotations and findings. The flexibility of on-premise, cloud, or hybrid deployment options provides adaptability to various IT infrastructures and data security policies, minimizing disruption during implementation.
Details
| Category | Oncology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing — Not specified |
| Deployment | Integrates with existing DICOM Node servers (e.g., PACS/RIS) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Rayvolve LN received FDA 510(k) clearance (K243831) on March 26, 2025. It is indicated as a computer-aided detection software device to assist radiologists in identifying and marking regions related to suspected pulmonary nodules from 6 to 30mm size on frontal (AP/PA) chest radiographs of patients 18 years of age or older, serving as a second reader. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Pulmonology, Radiology |
What the Web Says
Rayvolve LN is an AI-powered software designed to assist radiologists in identifying and marking suspected pulmonary nodules (6-30mm) on frontal chest X-rays for patients 18 years or older. It acts as a second reader to enhance diagnostic accuracy without replacing the original images. The broader Rayvolve AI Suite, which includes Rayvolve LN, is praised by physicians for improving diagnostic confidence, reducing interpretation time, and seamlessly integrating into existing PACS/RIS workflows.
Overall: PositiveStrengths
- Increases diagnostic accuracy and sensitivity for fracture detection and pulmonary nodules.
- Reduces interpretation and decision-making time for radiologists and emergency physicians.
- Seamlessly integrates into existing PACS/RIS workflows without additional clicks.
- Provides a safety net and reassurance for less experienced doctors and residents, especially during off-hours.
- Aids in managing rising imaging volumes while preserving diagnostic accuracy.
- FDA cleared and CE marked, with strong clinical validation and peer-reviewed studies.
Limitations
- No specific cons for Rayvolve LN were found in the search results.
- General AI limitations: AI tools are not 100% accurate and require radiologist input; they do not replace the final decision-making authority of physicians.
Based on reviews from: AZmed (via Google Search snippets), TestDynamics, Blackford Analysis, Innolitics
Last updated: 2026-07-18
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Press & Coverage
AZmed
Orthopedic AI in X-ray imaging for clinical evidence and use in 2026 - AZmed
This article discusses the clinical evidence and use of AI in orthopedic X-ray imaging, highlighting Rayvolve LN as a computer-aided detection software for suspected pulmonary nodules. It also mentions the regulatory status of Rayvolve in both the EU and US.
2026-04
AZmed
AZmed and RADIN Health partner to bring AI radiology tools to U.S. hospitals, imaging centers, and radiology practices
AZmed has partnered with RADIN Health to distribute its Rayvolveu00ae products, including AZtrauma for fracture detection and AZchest for thoracic abnormalities, to healthcare facilities across the U.S.
2026-04
AZmed
Rayvolve AI Suite now Available in Fujifilm Synapse PACS - AZmed
AZmed announced that its Rayvolve AI Suite, which includes Rayvolve LN for pulmonary nodule detection, is now integrated and available within Fujifilm Synapse PACS.
2026-03
AZmed
RADIO-LOG uses AZmed AI as a second-read safety net for X-rays
RADIO-LOG has implemented AZmed's AI solutions, including AZtrauma and AZchest, to help manage increased workload and ensure diagnostic precision in their radiology departments, particularly during critical periods.
2026-01
AZmed
AZnod Receives CE Marking for AI Lung Nodule Detection - AZmed
AZmed's Rayvolve LN, a computer-aided detection software for suspected pulmonary nodules, has received CE Marking, indicating its compliance with European Medical Device Regulation.
2025-12
AZmed
How AGAPLESION Uses Radiology AI to Improve Diagnostic Confidence with Rayvolve
AGAPLESION has deployed AZmed's Rayvolve AI Suite to enhance diagnostic confidence and support clinical judgment, especially for residents and trainees in emergency contexts.
2025-11
AZmed
AZmed l How AI in radiology delivers faster diagnosis with accuracy
This article highlights how AZmed's Rayvolve AI Suite, including Rayvolve LN, helps radiology departments achieve faster and more accurate diagnoses by automating tasks and providing reliable AI for various X-ray analyses.
2025-10
FDA
Rayvolve LN 510(k) Summary - FDA
The FDA 510(k) summary for Rayvolve LN details its intended use as a computer-aided detection software to assist radiologists in identifying and marking suspected pulmonary nodules from 6 to 30mm on frontal chest radiographs for patients 18 years or older.
2025-03
Videos
Product demos, reviews, and walkthroughs for Rayvolve LN.
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Frequently Asked Questions
Rayvolve LN is designed to seamlessly integrate into existing PACS/RIS workflows, functioning as a 'second reader' without requiring additional clicks or separate systems. Its primary function is to assist radiologists in identifying and marking suspected pulmonary nodules ranging from 6 to 30mm on frontal chest radiographs.
Yes, Rayvolve LN is FDA-cleared as a Class II medical device in the United States. Additionally, it is CE-marked as a Medical Device Class IIa in Europe, demonstrating compliance with the Medical Device Regulation (2017/745).
Rayvolve LN is specifically intended for detecting pulmonary nodules between 6 and 30mm in size on frontal chest radiographs of patients 18 years of age or older. It provides adjunctive information only and is not a substitute for the radiologist's interpretation or the original radiographic image.
Clinical studies indicate that AI-assisted reading with tools like Rayvolve can significantly improve diagnostic speed and performance, including a reduction in reading time and an increase in sensitivity for detecting thoracic anomalies. While no AI tool is 100% accurate, Rayvolve LN aims to enhance a radiologist's ability to identify potential nodules.
Rayvolve LN utilizes the DICOM image standard, allowing it to interact with existing DICOM Node servers like PACS, which are typically secured within a healthcare network. As a regulated medical device, it is expected to comply with relevant data protection regulations and standards, although specific privacy protocols for Rayvolve LN were not detailed in the search results.
Yes, Rayvolve LN is part of AZmed's broader Rayvolve AI Suite, which includes other modules like AZtrauma for fracture detection, AZchest for other chest abnormalities, AZmeasure, and AZboneage. Several other companies also offer AI solutions for chest X-ray analysis, such as Gleamer's ChestView and Lunit's INSIGHT CXR, which detect various thoracic pathologies.
While specific pricing figures for Rayvolve LN are not publicly detailed, other modules within the Rayvolve AI Suite, such as AZtrauma, are noted to operate on a subscription-based model, with pricing often determined by the number of analyses performed. It is likely that Rayvolve LN follows a similar commercial model.
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| Last Verified: 2026-04-17 | First Added: 2026-04-17