FDA Radiology AI Devices

Navigo Workstation 2.3 is a medical image processing system designed for radiology. It helps clinicians analyze radiological images by providing advanced image processing tools to assist in diagnosis and medical decision-making.

RiasDR is a software product designed to acquire and process digital radiographic images, helping clinicians by efficiently managing and enhancing X-ray images for diagnosis and treatment planning.

iPETcertum (v1.0) by Claritas HealthTech Pte Ltd is a radiological image processing system designed to assist clinicians by analyzing medical images to support patient diagnosis and management.

IMAGE ONE is a radiological image processing system developed by Infomed Software. It aids clinicians by processing medical images to enhance their interpretation and support diagnostic decisions.

Neuro Insight V1.0 by Olea Medical S.A.S. is an advanced image processing system designed for radiological applications. It helps clinicians by processing medical images, potentially enhancing the insight gained from them for neurological assessments.

GyriCalc (Version 1.0.0) is a radiological image processing system designed to assist clinicians by analyzing brain images. It helps in quantifying gyri patterns in the brain, which can aid in neurological assessments and diagnosis.

AV Viewer is a radiological image processing system designed to help clinicians view and analyze medical images more effectively. It assists healthcare providers by enhancing image visualization, supporting better diagnosis and patient care.

uOmniscan is a software that enables real-time remote collaboration and control of medical imaging devices, especially MRI scanners. It helps healthcare professionals remotely manage scans, train technicians, and enhance communication across different locations, increasing workflow efficiency and access to expert guidance.

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.

TechLive is a software application designed to enable healthcare professionals to remotely access and control medical imaging devices in real-time for image acquisition, assistance, review, and training. It supports multiple imaging modalities and fosters collaboration among clinical staff across different locations, improving operational support and training without being intended for diagnostic use.