FDA Radiology AI Devices

The Shear Wave Quantificational Ultrasound Diagnostic System is an advanced ultrasound machine that uses shear wave technology to provide quantitative assessment of tissue stiffness. This helps clinicians evaluate various conditions by producing detailed images and measurements, improving diagnosis and treatment planning.

Ligence Heart is an AI-driven software designed to automatically process radiological images for cardiac assessment. It helps clinicians by providing automated analysis of heart images, potentially improving diagnostic efficiency and accuracy.

Brain WMH by Quantib BV is an automated software tool designed to analyze brain MRI images for white matter hyperintensities (WMH). It helps clinicians identify and quantify these lesions, improving diagnosis and monitoring of neurological conditions.

Rapid Aortic Measurements is an AI-powered software product designed to automatically process radiological images to assist clinicians in measuring aortic structures quickly and accurately.

3D-SHAPER is a medical device that analyzes imaging data to measure bone density in three dimensions. It helps clinicians assess bone health more accurately, which is important for diagnosing conditions like osteoporosis and planning treatments.

Careverse CoronaryDoc is an automated software designed for processing radiological images, helping clinicians analyze coronary images more efficiently and accurately.

The UNiD™ Spine Analyzer by Medicrea International is a software tool designed to automatically process radiological images of the spine. It helps clinicians by providing detailed analysis of spinal images, which facilitates diagnosis and treatment planning for spinal conditions.

Voxel Dosimetry is a software tool used in nuclear medicine to calculate the absorbed radiation dose distribution within a patient's body at the small voxel level and for specific organs. It uses deep learning based semi-automatic segmentation and non-rigid image registration to analyze images post-radionuclide therapy, providing clinicians with detailed dose mapping to assist in treatment planning and evaluation.

Synapse PACS (7.5) by FUJIFILM Healthcare Americas Corporation is a web-based software application designed to manage, display, and process medical images from various modalities. It provides advanced tools such as measurements, regional segmentation, 3D volume rendering, fusion, and structured report generation to support clinicians like radiologists and cardiologists in reading, interpreting, and planning patient care efficiently.

EchoConfidence (USA) is an AI-powered software that helps clinicians analyze transthoracic echocardiogram images. It automatically classifies views, segments cardiac structures, measures cardiac function, and performs Doppler assessments, improving the efficiency and accuracy of cardiac image interpretation for adults and adolescents.