FDA Radiology AI Devices

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced ultrasound systems designed for diagnostic imaging and fluid flow analysis across multiple body regions. They include an AI software feature called R-Trigger that detects R-wave peaks from cardiac cycles without requiring ECG input, aiding automated cardiac measurements to simplify and improve workflow for clinicians during transthoracic echo exams.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC provide advanced ultrasound imaging and fluid flow analysis for various body regions, including cardiac adult imaging. These systems incorporate AI-driven software features such as Segmental Wall Motion Version 2 (SWM v2) and Auto EF with contrast, which assist clinicians in automating the evaluation of left ventricular function and ejection fraction using transthoracic echocardiography. This helps healthcare providers make more accurate and efficient cardiac assessments during diagnostic imaging.

BrightHeart View Classifier is an AI-powered software that automatically analyzes fetal ultrasound images and video clips to identify standard views of the fetal heart during scans. It helps healthcare professionals by improving the acquisition and interpretation of fetal heart ultrasound exams, making fetal heart imaging more efficient and consistent.

Fetal EchoScan (v1.1) is an AI-driven software device that assists physicians in interpreting second-trimester fetal heart ultrasound videos. It detects suspicious morphological features indicative of congenital heart defects, helping clinicians identify potential heart abnormalities in unborn babies during routine ultrasound exams. The software acts as a concurrent reading aid, providing annotative outputs to improve diagnostic accuracy and support clinical decision-making for fetal cardiac assessment.

The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is software designed to help physicians analyze and observe images from ultrasound examinations. It supports data from specific diagnostic ultrasound systems and includes AI-enabled features for advanced cardiac motion tracking and measurement, aiding clinical decision-making in hospital and clinical settings.

LARALAB is an AI-powered medical imaging software that helps cardiologists, radiologists, and heart surgeons visualize, assess, and measure cardiovascular structures from medical images. It automates segmentation and measurements to assist in preprocedural planning and postprocedural review, improving workflow efficiency and accuracy in cardiovascular care.

Vitrea CT VScore is a software application designed to aid medical professionals in visualizing, segmenting, and quantifying calcified lesions in ECG-gated cardiac CT images of patients aged 30 years or older. It provides calcium scoring and generates detailed reports to assist clinicians in cardiac imaging assessment.

HeartFocus (V.1.1.1) is an AI-powered software accessory designed to help healthcare professionals acquire high-quality 2D cardiac ultrasound images. It guides users in real-time to position the ultrasound probe correctly and detects when images meet diagnostic quality. This assists both experienced sonographers and less trained medical professionals in capturing standardized heart views, improving the quality and consistency of cardiac ultrasound exams.

QFR (3.0) is a software device that processes X-ray angiogram images to provide quantitative analysis of coronary vessels. It uses deep learning and 3D reconstruction from angiographic images to measure vessel dimensions and quantify pressure drops, aiding cardiologists in evaluating coronary artery disease and supporting treatment decisions.

Salix Central is a cloud-based software that helps cardiologists and radiologists analyze cardiac CT scans. It assists in identifying coronary plaques, stenosis, and performing calcium scoring, supporting clinical decision-making in assessing heart disease.