FDA Radiology AI Devices

Salix Coronary Plaque (V1.0.0) is an AI-powered software designed to automatically process and analyze radiological images, specifically helping clinicians assess coronary artery plaques to improve cardiac care.

DS Core Diagnosis by Dentsply Sirona Inc. is an AI-powered software designed to process radiological images automatically. It helps clinicians by analyzing medical images, enabling more efficient and accurate diagnosis in radiology.

Genius AI Detection 2.0 is a software tool that uses artificial intelligence and deep learning to help radiologists detect and evaluate potential breast abnormalities in 3D mammography (digital breast tomosynthesis) images. It marks suspicious soft tissue densities and calcifications, provides confidence scores, and supports radiologists in their interpretation during the exam reading, enhancing breast cancer screening accuracy and efficiency.

The Venue series from GE Medical Systems includes advanced ultrasound systems that use pulsed Doppler technology to help clinicians capture live images and blood flow information. These devices assist in diagnostic imaging by providing high-quality ultrasound scans useful in a variety of clinical applications.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices used by clinicians to perform detailed diagnostic examinations. They help visualize internal structures in the body using pulsed Doppler ultrasound, aiding in the assessment and diagnosis of various medical conditions.

The B-Scan device by ACCUTOME, INC. is an ultrasound imaging system that uses pulsed echo technology to capture images inside the body. It assists clinicians by providing detailed images useful for diagnosis and treatment planning in radiology.

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

The Sonosite LX Ultrasound System by FUJIFILM Sonosite is an advanced ultrasound imaging device used in medical settings. It assists clinicians by providing high-quality ultrasound and Doppler images, facilitating diagnosis and patient care in radiology.

MammoScreen® is an AI-based software designed to assist radiologists in detecting and diagnosing lesions that may be indicative of breast cancer from mammography images. It helps improve accuracy and efficiency by highlighting suspicious areas, supporting earlier and more reliable cancer detection.

Bunkerhill Abdominal Aortic Quantification (AAQ) is AI software designed to analyze radiological images to quantify the abdominal aorta. This helps clinicians assess and monitor conditions related to the abdominal aorta more efficiently and accurately.