FDA Radiology AI Devices

The syngo.CT Lung CAD by Siemens Healthcare GmbH is a software tool designed to assist radiologists in detecting solid and subsolid lung nodules on chest CT scans. It uses advanced AI algorithms based on convolutional neural networks to highlight suspicious areas, reducing the chance of missed nodules. The software integrates with existing medical imaging platforms, improving clinicians' efficiency and accuracy in lung nodule detection, a critical task in lung cancer screening and diagnosis.

Oxehealth Vital Signs is a software device that analyzes video images captured by standard cameras to noninvasively measure a patient's pulse rate and estimated breathing rate. It uses proprietary algorithms to monitor skin pixel intensity changes and chest wall movements, allowing healthcare staff to perform vital sign spot checks without disturbing the patient. This is especially useful in hospital or secured environments where minimizing patient contact is advantageous.

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is a whole-body CT scanner that can capture detailed cross-sectional volume images of organs in a single rotation. It uses advanced AI algorithms such as deep convolutional neural networks to improve image quality and reduce noise, helping clinicians to better visualize anatomy and potentially optimize iodinated contrast media use. The spectral imaging system acquires images at different energy levels nearly simultaneously to differentiate tissues and materials, assisting in diagnosis and treatment planning.

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

VBrain is an AI-powered software device that helps trained medical professionals by automatically generating initial contours of known brain tumors on MRI scans. It supports radiation therapy planning by providing preliminary tumor outlines for professionals to review and adjust, streamlining the clinical workflow for brain tumor treatment planning.

ProFound AI Software V3.0 is an AI-based medical imaging software that aids radiologists by detecting and highlighting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It provides confidence scores that help clinicians identify potentially malignant findings more quickly and accurately during breast cancer screening and diagnosis.

Oncospace is a software system designed to assist radiation oncologists and medical dosimetrists in planning radiotherapy treatments for prostate, thoracic, pancreas, and head & neck cancers. It uses machine learning to predict personalized dose goals for organs at risk, helping clinicians optimize treatment plans more efficiently and safely, potentially reducing the number of iterations needed for plan approval.

Imbio RV/LV Software is an AI-powered medical imaging tool that automatically measures the diameters of the right and left ventricles of the heart from CT pulmonary angiography scans. It provides annotated images and reports to assist physicians in evaluating heart function, supporting clinical decision-making as part of cardiac assessment workflows.

Optellum Virtual Nodule Clinic is an AI-powered software that helps medical professionals track, assess, and characterize pulmonary nodules detected incidentally in CT scans. It provides a malignancy likelihood score using a convolutional neural network to support clinical decision making, improving diagnostic accuracy and patient management workflows for lung nodules.

The Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is an advanced 3 Tesla MRI system by Canon Medical Systems. It utilizes AI-based deep learning reconstruction to improve image quality across various anatomical regions. This helps clinicians by providing clearer, high-quality diagnostic images of the head, body, and multiple specific anatomical areas, improving diagnostic confidence without changing the existing hardware or basic MRI functions.