FDA Radiology AI Devices

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.

Sonio Suspect is a cloud-based AI software designed to assist clinicians during or after fetal ultrasound examinations by automatically detecting and characterizing abnormal fetal findings. It helps healthcare professionals identify potential issues in fetal development, improving diagnostic accuracy and supporting better patient management decisions.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.

Fetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.

EchoSolv AS is a cloud-based AI and machine learning decision support software designed to help cardiologists assess severe aortic stenosis (AS) from transthoracic echocardiogram data and patient demographics. It provides a categorical probability of severe AS to assist in diagnosis alongside clinical guidelines, improving identification accuracy and supporting patient management decisions during echocardiogram interpretation.

AISAP Cardio V1.0 is an AI-powered software that analyzes cardiac point-of-care ultrasound images to detect and assess valvular pathologies like regurgitations and stenosis, and measures key cardiac functions such as ejection fraction and chamber sizes. It supports physicians by generating diagnostic reports that aid in interpreting ultrasound images, improving accuracy and efficiency in evaluating heart conditions in adult patients.

Koios DS is a web-based AI software that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules suspicious for cancer. It automatically selects regions of interest, classifies lesions using standardized lexicons like BI-RADS and TI-RADS, provides cancer risk assessments, and generates structured reports to aid in clinical decision-making, improving diagnostic accuracy and reducing variability.

EchoGo Pro is an AI-powered software tool designed to assist physicians in diagnosing coronary artery disease by analyzing stress echocardiography ultrasound images. It processes images acquired during stress echo exams, automatically segments the left ventricle, and uses machine learning to provide a categorical assessment of the likelihood of significant CAD, helping clinicians make more accurate and consistent diagnoses.

Koios DS for Breast is a machine learning-based software that assists physicians in analyzing ultrasound images of breast lesions. It helps classify breast lesions into BI-RADS categories to support diagnostic accuracy, improve consistency between readers, and provide useful visual confidence indicators. The software processes selected regions of interest on ultrasound images and provides diagnostic support to clinicians.