FDA Radiology AI Devices

The 5000 Compact Series Ultrasound Systems by Philips Ultrasound LLC is a diagnostic ultrasound imaging system equipped with an AI-powered Auto Measure feature. It provides semi-automated, editable 2D and Doppler measurements primarily for adult echocardiography, helping clinicians obtain accurate cardiac measures efficiently. The system supports a wide range of clinical applications including cardiac, abdominal, vascular, obstetric, and musculoskeletal imaging, and is used in various clinical settings such as hospitals and clinics.

The EPIQ Series Diagnostic Ultrasound System by Philips is an advanced ultrasound imaging device that uses AI-powered software to aid clinicians in semi-automated quantification of heart valve function, specifically assessing the tricuspid valve and mitral valve regurgitation. This helps improve accuracy and efficiency in diagnosing cardiac conditions by providing detailed measurements and flow analysis from 3D ultrasound images.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that include innovative AI-powered software features. The Smart View Select software automatically selects optimal heart images for analysis, while the Segmental Wall Motion software evaluates the movement of specific regions of the heart's left ventricle. These tools help clinicians perform more efficient and precise cardiac assessments, enhancing diagnosis and treatment planning.

The Lumify Diagnostic Ultrasound System by Philips Ultrasound is a transportable ultrasound device that provides high-resolution diagnostic imaging across various modes including B-mode, Doppler, and M-mode. It incorporates an AI-based software feature that automatically detects and quantifies lung B-lines and merged B-lines from ultrasound videos to assist clinicians in assessing lung conditions such as pneumonia and pulmonary edema. The system supports multiple transducers and is designed for use by healthcare professionals in diverse clinical settings.