FDA Radiology AI Devices

TINGSN FINDERS 2 is a color Doppler ultrasound system that helps clinicians visualize and assess blood flow and heart function using pulsed Doppler ultrasound technology. It assists in cardiovascular diagnosis by providing detailed images and flow information in real time.

The FloPatch FP120 is a non-invasive cardiovascular blood flowmeter intended for use by medical professionals in hospitals and clinical settings. It utilizes continuous wave Doppler ultrasound to assess blood flow in peripheral vasculature. The device wirelessly transmits Doppler signals to a mobile application that displays blood flow measurements such as Max Velocity, Velocity Time Integral (VTI), and Corrected Flow Time, helping clinicians noninvasively monitor vascular health.

Us2.ca is a clinical decision support tool that automatically analyzes echocardiogram images to assist cardiologists and healthcare professionals in identifying patients with potential cardiac amyloidosis. It improves clinical workflow by providing AI-derived measurements and report generation, helping clinicians focus on cases needing further follow-up, but it does not replace a formal diagnosis or current care standards.

The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters are reprocessed ultrasound catheters used in cardiac electrophysiology procedures. They provide real-time 2D ultrasound imaging and 3D location sensing inside the heart and great vessels to help clinicians visualize anatomy and other procedural devices during interventions.

InVision Precision Cardiac Amyloid is a software tool that uses machine learning to analyze echocardiogram videos and identify signs of cardiac amyloidosis in patients aged 65 and older. It integrates with existing hospital imaging systems and helps physicians screen patients by providing decision support alerts to guide referrals for further confirmatory tests.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a medical device designed to image the inside of coronary and peripheral blood vessels using ultrasound. It provides real-time cross-sectional images to help clinicians evaluate vessel morphology as an adjunct to angiography, aiding in diagnosis and treatment planning for cardiovascular conditions.

The VeriSight Intracardiac Echocardiography Catheters (VSICE2D and VSICE3D) are disposable devices used during cardiac procedures to provide real-time ultrasound imaging inside the heart and nearby vessels. They help clinicians visualize cardiac anatomy and physiology in both adult and pediatric patients for guidance during interventions, improving the accuracy and safety of heart treatments.

The VERAFEYE System by Luma Vision Limited is an advanced ultrasound imaging tool designed for real-time visualization inside the heart and great vessels during cardiac procedures. It includes a sterile catheter and an imaging console that creates 2D and 3D ultrasound images to help clinicians see cardiac anatomy and physiology, guiding interventions safely and accurately.

The Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter is a reprocessed ultrasound catheter designed for imaging inside the heart and great vessels of adult patients. It assists clinicians by providing intracardiac and intraluminal visualization using the ultrasound modality. The catheter is intended for imaging guidance during cardiac interventional procedures, improving visualization of cardiac anatomy and device placement without treatment delivery.

The Falcon/Xpress is a compact, portable ultrasonic diagnostic device designed for the noninvasive evaluation of peripheral vascular conditions. It uses pneumatic pressure measurements, Doppler ultrasound, and photo-plethysmography to assess blood flow and vascular health in various limb sites. This helps clinicians diagnose vascular diseases and monitor vascular function with specialized testing protocols.