FDA Radiology AI Devices

Videa Dental AI is a medical imaging AI product designed to analyze radiology images related to dental applications. It helps clinicians by providing automated assessment of dental images, supporting decision-making and improving diagnostic efficiency.

The uDR Aurora CX is a stationary X-Ray system designed for radiology applications. It helps clinicians obtain high-quality X-Ray images which can be used for diagnostic purposes, potentially supporting AI tools in image analysis and patient care.

The ULTRASONIC PROBE UM-3R and UM-G20-29R are diagnostic ultrasonic transducers used to produce ultrasound images for medical evaluation. These probes help clinicians visualize internal organs and tissues noninvasively to aid in diagnosis and treatment planning.

Axial3D Insight is a software that automatically processes radiological images to help clinicians analyze complex anatomical structures. It aims to enhance medical imaging interpretation and assist in treatment planning.

The ECHELON Synergy is an MRI system developed by Fujifilm Corporation that helps clinicians obtain detailed images of internal body structures using nuclear magnetic resonance. This enables doctors to diagnose and monitor various medical conditions with precision.

Insight Enhanced™ DRF is a fluoroscopic X-ray system used in radiology to capture dynamic real-time images of the body, assisting clinicians in diagnosis and treatment by providing enhanced visualization during procedures.

The BONX805 is a mobile X-ray system designed for radiology applications. It helps clinicians by providing portable X-ray imaging capabilities, facilitating diagnostic imaging in various clinical settings where mobility is essential.

The ViewMate Ultrasound System by Shenzhen Mindray is a pulsed Doppler ultrasound imaging system. It provides clinicians with ultrasound imaging capabilities to assist in diagnostic examinations, helping to visualize blood flow and other physiological data non-invasively.

The uWS-Angio is an image processing system used in radiology to assist clinicians by enhancing and analyzing medical images, improving diagnosis and patient care.

The Hypertension Notification Feature (HTNF) is a software-only mobile medical application by Apple that uses AI to analyze pulse sensor data collected by Apple Watch to notify users of possible hypertension. It helps adults over 22 years who are not diagnosed with hypertension to identify potential high blood pressure patterns, guiding them for further evaluation, but it is not a diagnostic or monitoring tool. It is designed for over-the-counter use, providing accessible cardiovascular health insights from wearable technology.