FDA Radiology AI Devices

EchoGo Heart Failure 2.0 is an AI-powered software tool that analyzes echocardiogram images of the heart's apical four-chamber view to support clinicians in detecting heart failure with preserved ejection fraction (HFpEF). It provides a diagnostic aid by outputting a classification and a confidence score, enhancing cardiovascular assessments and helping guide clinical decision-making.

PIUR tUS Infinity is a computer-aided detection system that assists medical professionals by analyzing ultrasound images of the thyroid and thyroid nodules. It uses AI and machine learning algorithms to create 3D volume reconstructions from 2D ultrasound images, allowing quantification and visualization of thyroid nodules to aid diagnosis. The system integrates seamlessly with FDA-cleared ultrasound equipment and produces reports to support clinical decisions.

CINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 by Canon Medical Systems Corporation is a high-quality ultrasound imaging device designed for use in diverse clinical applications, such as cardiac, abdominal, musculoskeletal, fetal, and small organs imaging. It provides advanced imaging modes including Doppler, Harmonic Imaging, Elastography, and AI-based improvements like Auto Plane Detection and Quick Strain to enhance workflow efficiency and diagnostic accuracy for clinicians.

Constellation (CON-001) is an automated software tool that processes whole-body MRI images to segment anatomical regions and quantify various tissues such as muscles, fat, and organs. It provides clinicians with detailed quantitative reports with visual overlays to support clinical decisions without making autonomous diagnoses, focusing on healthy adult patients.

FETOLY-HEART is a software tool that helps healthcare professionals during fetal ultrasound exams by automatically detecting key fetal heart views and assessing the quality of those views in real-time. It supports clinicians in ensuring a complete and accurate fetal heart examination, particularly in the second and third trimesters of pregnancy, improving diagnostic confidence and workflow efficiency.

LumiNE US is a visualization software designed to help neurosurgeons and medical professionals prepare for surgery by converting 2D MRI and CT images into 3D models using AI-based segmentation. It enables visualization through augmented reality using head-mounted displays, assisting in understanding brain tumors and anatomy before surgery. The software is not intended for diagnostic use but to support surgical planning by providing enhanced image insights.

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is an AI-powered software that assists medical professionals in analyzing thyroid ultrasound images by automatically localizing thyroid nodules and characterizing them using standardized descriptors based on ACR TI-RADS. It helps clinicians generate structured reports and improves accuracy in detection and classification of nodules, thereby supporting clinical decision-making in thyroid nodule management.

Overjet Image Enhancement Assist is a software tool that improves the quality of dental x-ray images such as bitewing, periapical, and panoramic images. It uses AI algorithms to reduce noise and enhance contrast and sharpness, helping dental professionals see clearer images for better diagnosis. The software operates within the Overjet device platform and is intended to be an optional enhancement tool, not a replacement for existing imaging systems.

ADAS 3D is an AI-powered software tool that processes cardiac MRI and CT images to support visualization, quantification, and analysis of heart structures and myocardial fibrosis in patients with cardiovascular disease. It aids medical professionals in making informed decisions for cardiac care by providing detailed 3D imaging data, especially for pre-planning and during electrophysiology procedures.