FDA Radiology AI Devices

Merge Universal Viewer (MUV) is a software application that provides healthcare professionals internet access to view, analyze, and share medical images from multiple imaging modalities. It supports diagnostic workflows by enabling display and manipulation of radiological images, and can output digital files for 3D printing. The viewer facilitates image review, reporting, and data sharing, thus improving accessibility and efficiency in radiology departments.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced diagnostic ultrasound imaging systems used in various clinical settings, including hospitals and clinics. They provide imaging and fluid flow analysis of multiple body regions through modes like B Mode, Doppler, and Harmonic Imaging, helping clinicians diagnose a wide range of conditions. A new Remote Software Management feature enhances workflow by allowing remote software upgrades and maintenance, improving system availability and usability without hardware changes.

Horos Mobile is a mobile software application that allows trained healthcare professionals to view and review medical images from CT, MRI, X-ray, ultrasound and other DICOM compliant systems on iOS and iPadOS devices. It facilitates diagnostic image visualization remotely or when full workstations are not available, supporting essential tools for image manipulation and measurement consistent with clinical practice requirements.

The EXPD 114 series are digital flat panel X-ray detectors designed to capture radiographic images electronically instead of traditional film. These devices convert incoming X-rays into visible light and then into digital signals for immediate viewing, storage, and analysis. The detectors are intended for general radiographic diagnosis and can replace traditional film or screen-based systems, assisting clinicians with quick and efficient patient imaging for a wide range of examinations in both adult and pediatric populations.

The EXPD-N series by DRTECH Corporation is a digital flat panel X-ray detector designed for use in digital radiography. It replaces traditional film or screen-based X-ray systems and aids clinicians by providing high-quality digital images for general diagnostic imaging of human anatomy in both adults and children. It supports improved imaging performance and faster image acquisition for better diagnosis.

The Lux HD 35 Detector and Lux HD 43 Detector by iRay Imaging Technology are digital flat panel X-ray detectors designed to provide high-resolution digital radiographic imaging for adult and pediatric patients. These detectors replace traditional film/screen systems in general radiography and connect wirelessly or via wired interfaces to DR systems, aiding clinicians in capturing and processing X-ray images for diagnosis efficiently.

The SIGNA Prime Elite is a whole body magnetic resonance imaging (MRI) scanner that offers high resolution and short scan times. It produces detailed images across multiple planes of the entire body, including the head, spine, heart, and musculoskeletal regions, assisting physicians in diagnostic interpretation to support detection and evaluation of various medical conditions.

SERV MEDICAL CDSS is a medical image processing software designed for trained professionals, enabling viewing, processing, and analysis of imaging data acquired with Digital Subtraction Angiography (DSA). It helps clinicians visualize large vessels and supports clinical decision making by providing comprehensive image viewing and analysis capabilities on standard hardware.

The Ziehm Solo FD is a mobile fluoroscopic X-ray imaging device designed for both adult and pediatric patients. It provides real-time pulsed and continuous fluoroscopic imaging to assist clinicians during diagnostic, interventional, and surgical procedures across various specialties such as orthopedics, neurology, vascular, and cardiac care. The device enhances visualization of anatomical structures, helping improve clinical outcomes through high-quality digital images and cine loops capture.

The BodyTom 64 is a computed tomography (CT) system designed for pediatric and adult imaging within an 85 cm aperture. It offers high-resolution CT scans with preset dose settings based on patient age and weight and can be used with or without contrast. The system is specifically intended for various diagnostic uses, including low dose lung cancer screening when used with established protocols. Its design includes a mobile gantry with a rotating disk x-ray generator and detector array, facilitating imaging at different clinical locations. The system includes an interventional radiology package that enhances clinical workflow and user experience.