FDA Radiology AI Devices

Allix5 is a software tool that uses medical imaging data to help predict a patient's future risk of developing breast cancer. This helps clinicians identify patients who may need closer monitoring or preventive care.

BrightHeart View Classifier is an AI-powered software that automatically analyzes fetal ultrasound images and video clips to identify standard views of the fetal heart during scans. It helps healthcare professionals by improving the acquisition and interpretation of fetal heart ultrasound exams, making fetal heart imaging more efficient and consistent.

Fetal EchoScan (v1.1) is an AI-driven software device that assists physicians in interpreting second-trimester fetal heart ultrasound videos. It detects suspicious morphological features indicative of congenital heart defects, helping clinicians identify potential heart abnormalities in unborn babies during routine ultrasound exams. The software acts as a concurrent reading aid, providing annotative outputs to improve diagnostic accuracy and support clinical decision-making for fetal cardiac assessment.

BunkerHill BMD is an AI-based software tool designed to estimate bone mineral density from existing CT scans of the spine in adults aged 30 and over. It helps clinicians identify low bone density without requiring dedicated bone densitometry scans, supporting retrospective assessment and aiding clinical decision-making.

Salix Central is a cloud-based software that helps cardiologists and radiologists analyze cardiac CT scans. It assists in identifying coronary plaques, stenosis, and performing calcium scoring, supporting clinical decision-making in assessing heart disease.

HeartSee Cardiac P.E.T. Processing Software is a tool that helps trained clinicians analyze heart PET images to quantify blood flow and heart function. It provides detailed maps and measurements that assist in diagnosing coronary artery disease by measuring myocardial perfusion and coronary flow reserve. This enables better clinical interpretation and patient management based on quantitative PET imaging data.

TBS iNsight (V4) is a software tool that processes bone density images from DXA scans to calculate a Trabecular Bone Score (TBS). This score helps clinicians assess bone quality and fracture risk, complementing standard bone density measurements. The software improves the accuracy of evaluating osteoporosis and bone health, aiding in diagnosis and treatment monitoring.

ScreenDx is an AI-powered software device that analyzes lung CT scans to identify patterns suggestive of interstitial lung disease. It provides clinicians with a qualitative output to help refer patients who may benefit from further assessment of lung fibrosis, supplementing standard care workflows but not replacing diagnostic methods.

Saige-Density is a software tool that analyzes digital mammography and breast tomosynthesis images to categorize breast density according to the ACR BI-RADS Atlas 5th Edition. It aids radiologists by providing adjunctive information to help assess breast tissue composition, improving the evaluation process, although it is not a diagnostic aid itself.

The ULTIMUS Series Ultrasound Diagnostic System by Vinno Technology (Suzhou) Co., Ltd is a mobile diagnostic ultrasound system designed to assist qualified physicians in imaging and analyzing various parts of the human body and fluids. It supports multiple clinical applications including abdominal, fetal/obstetrics, gynecology, cardiac, vascular, musculoskeletal, and pediatric imaging with advanced imaging modes like 3D/4D, Doppler, elastography, and contrast imaging. The system provides high-quality ultrasound imaging and measurement capabilities intended for hospitals and clinics to enhance diagnostic confidence and patient management.