FDA Radiology AI Devices

Rapid CTA 360 by iSchemaView is an AI software designed to assist radiologists by automatically triaging and notifying critical findings on CT angiography scans. This helps clinicians quickly identify urgent conditions and prioritize patient care effectively.

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.

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.

BriefCase-Triage by Aidoc Medical, Ltd. is an AI-powered software designed to assist radiologists by analyzing CT chest and abdomen scans and flagging cases with suspected aortic dissection. It helps medical specialists prioritize urgent cases by sending notifications and preview images, improving workflow efficiency without altering the original medical images or replacing diagnostic interpretation.

uWS-Angio Basic is medical image management and processing software designed to handle X-ray angiographic, CT, and MRI images. It provides clinicians with tools for viewing, processing, calibration, and measurement of 2D and 3D vascular images, supporting improved diagnosis and treatment planning in angiography and related procedures.

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 uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.

EchoGuide is a portable 3D ultrasound imaging device designed to assist healthcare providers in identifying the proper vascular access points on the skin for patients with arteriovenous fistulas or grafts. It automates ultrasound imaging acquisition and displays live coronal plane images to guide clinicians during cannulation, improving accuracy and ease of use during the procedure.

The Cornaris Intravascular Imaging System (P80-E and Mobile-E) with the LumenCross Imaging Catheter (F2) is an advanced intravascular imaging system designed to help clinicians visualize coronary arteries during transluminal interventional procedures. It uses optical coherence tomography technology to provide high-resolution images of the inside of blood vessels, aiding in diagnosis and treatment planning for patients with coronary artery conditions. The system enhances the ability to assess blood vessels safely and effectively, improving patient outcomes.

cmAngio® (V1.6) is an AI-based software product designed to assist radiologists by automatically processing radiological images, potentially helping to detect or analyze vascular conditions.