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 VIVIX-S 1751S is a digital flat panel X-ray detector designed for general-purpose diagnostic radiographic procedures. It replaces traditional film/screen X-ray systems by capturing and converting X-ray photons into digital images. This helps clinicians obtain high-quality digital X-ray images quickly and efficiently for better diagnosis.

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

Fetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.

Change Healthcare Stratus Imaging PACS is a cloud-based software system that manages and processes medical images to assist healthcare professionals in diagnosing and interpreting medical images. It offers features like image manipulation, enhancement, and 3D/4D visualization through a zero-footprint browser-based viewer. It supports clinicians by providing tools for reviewing and analyzing images acquired from DICOM-compliant devices, improving workflow with integrated reporting tools and secure access from clinical or remote locations.

The PRORAD X-Ray Flat Panel Detector with DROC is a digital radiography system designed to capture and display X-ray images of human anatomy. It is intended for general projection radiographic applications and helps clinicians by digitizing X-ray images for faster, more flexible image viewing and processing. The detector incorporates software that supports image workflow, viewing, measurement, and DICOM connectivity, streamlining radiographic exams and image management in clinical settings.

The UbiqVue 2A Multi-parameter System is a wireless wearable biosensor system for continuous monitoring of vital signs such as ECG, heart rate, respiration, temperature, SpO2, and blood pressure (optional). It transmits data wirelessly to a central server for storage, display, and analysis, enabling healthcare professionals to remotely monitor multiple patients at home and in clinical settings with alert notifications and visual alarms for abnormal physiologic parameters.

Frontier X Plus is a wearable ECG event recorder that monitors heart rhythms by capturing single-channel ECG signals via a chest strap. It automatically analyzes the ECG data using an embedded algorithm to detect arrhythmias such as atrial fibrillation, bradycardia, and tachycardia. The device helps clinicians monitor and diagnose heart conditions in adult patients, particularly those with suspected or known cardiac issues, by storing and transferring ECG data for physician review.

Hybrid Viewer is a software application used in nuclear medicine and radiology that processes and analyzes imaging data to help clinicians assess physiological or pathological states. It supports predefined workflows optimized for specific nuclear medicine studies and allows quantitative analysis to assist clinical management, though it does not replace visual assessment.

The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.