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Rayvolve LN is a computer-aided detection software device to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30mm size. It is designed to aid radiologists in reviewing the frontal (AP/PA) chest radiographs of patients of 18 years of age or older acquired on digital radiographic systems as a second reader and be used with any DICOM Node server. Rayvolve LN provides adjunctive information only and is not a substitute for the original chest radiographic image.

The medical device is called Rayvolve LN. Rayvolve LN is one of the verticals of the Rayvolve product line. It is a standalone software that uses deep learning techniques to detect and localize pulmonary nodules on chest X-rays. Rayvolve LN is intended to be used as an aided-diagnosis device and does not operate autonomously. Rayvolve LN has been developed to use the current edition of the DICOM image standard. DICOM is the international standard for transmitting, storing, retrieving, printing, processing, and displaying medical imaging. Using the DICOM standard allows Rayvolve LN to interact with existing DICOM Node servers (eg.: PACS) and clinical-grade image viewers. The device is designed for running on-premise, cloud platform, connected to the radiology center local network, and can interact with the DICOM Node server. When remotely connected to a medical center DICOM Node server, Rayvolve LN directly interacts with the DICOM files to output the prediction (potential presence of pulmonary nodules) the original image appears first, followed by the image processed by Rayvolve. Rayvolve LN does not intend to replace medical doctors. The instructions for use are strictly and systematically transmitted to each user and used to train them on Rayvolve LN's use.

Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in DICOM node servers for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist. Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

Rayvolve PTX-PE is a software-only device designed to help healthcare professionals. It's a radiological computer-assisted triage and notification software that analyzes chest x-ray imaqes (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). It is intended to work in combination with DICOM node servers. Rayvolve PTX-PE has been developed to use the current edition of the DICOM image standard. DICOM is the international standard for transmitting, storing, retrieving, printing, processing, and displaying medical imaging. Using the DICOM standard allows Rayvolve PTX-PE to interact with existing DICOM node servers (eg .: PACS), and clinical-grade image viewers. The device is designed to run on a cloud platform and be connected to the radiology center's local network. It can also interact with the DICOM Node server. When remotely connected to a medical center DICOM Node server, the software utilizes Al-based analysis algorithms to analyze chest X-rays for features suggestive of critical findings and provide study-level outputs to the DICOM node server for worklist prioritization. Following receipt of chest X-rays, the software device automatically analyzes each image to detect features suggestive of pneumothorax and/or pleural effusion. Rayvolve PTX-PE filters and downloads only X-rays with organs determined from the DICOM Node server. As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained health professional. Rayvolve PTX-PE is not intended to direct attention to a specific portion of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. Rayvolve PTX-PE does not intend to replace medical doctors. The instructions for use are strictly and systematically transmitted to each user and used to train them on Rayvolve's use.

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculosketal system. Rayvolve is indicated for adult and pediatric population (≥ 2 years). Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. Study type (Anatomic Area of interest) / Radiographic Views* supported: Ankle/ AP, Lateral, Oblique Clavicle/ AP, AP Angulated View Elbow/ AP, Lateral Forearm/ AP, Lateral Hip /AP, Frog-leg lateral Humerus /AP, Lateral Knee/ AP, Lateral Pelvis /AP Shoulder/ AP, Lateral, Axillary Tibia/fibula/ AP, Lateral Wrist/ PA, Lateral, Oblique Hand / PA, Lateral, Oblique Foot/ AP, Lateral, Oblique. * Definitions of anatomic area of interest and radiographic views are consistent with the ACR-SPR-SSR Practice Parameter for the Performance of Radiography of the Extremities guideline.

The medical device is called Rayvolve. It is a standalone software that uses deep learning techniques to detect and localize fractures on osteoarticular X-rays. Rayvolve is intended to be used as an aided-diagnosis device and does not operate autonomously. Rayvolve has been developed to use the current edition of the DICOM image standard. DICOM is the international standard for transmitting, storing, printing, processing, and displaying medical imaging. Using the DICOM standard allows Rayvolve to interact with existing DICOM Node servers (eg.: PACS) and clinical-grade image viewers. The device is designed for running on-premise, cloud platform, connected to the radiology center local network, and can interact with the DICOM Node server. When remotely connected to a medical center DICOM Node server. Rayvolve directly interacts with the DICOM files to output the prediction (potential presence or absence of fracture) the initial image appears first, followed by the image processed by Ravvolve. Rayvolve does not intend to replace medical doctors. The instructions for use are strictly and systematically transmitted to each user and used to train them on Ravvolve's use.

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adults only (≥ 22 years old). Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. Study Type (Anatomic Area of interest) / Radiographic Views supported: Ankle / Frontal, Lateral,Oblique Clavicle / Frontal Elbow / Frontal, Lateral Forearm / Frontal, Lateral Hip / Frontal, Frog Leg Lateral Humerus / Frontal, Lateral Knee / Frontal, Lateral Pelvis / Frontal Shoulder / Frontal, Lateral, Axillary Tibia/fibula / Frontal. Lateral Wrist / Frontal, Lateral, Oblique Hand / Frontal, Lateral Foot / Frontal, Lateral *For the purposes of this table, "Frontal" is considered inclusive of both posteroanterior (PA) and anteroposterior (AP) views. +Definitions of anatomic area of interest and radiographic views are consistent with the American College of Radiology (ACR) standards and guidelines.

The medical device is called Rayvolve. It is a standalone software that uses deep learning techniques to detect and localize fractures on osteoarticular X-rays. Rayvolve is intended to be used as an aided-diagnosis device and does not operate autonomously. It is intended to work in combination with Picture Archiving and communication system (PACS) servers. When remotely connected to a medical center PACS server, Rayvolve directly interacts with the DICOM files to output the prediction (potential presence of fracture). Rayvolve does not intend to replace medical doctors. The instructions for use are strictly and systematically transmitted to each user and used to train them on Rayvolve's use.