FDA Radiology AI Devices

EchoGuide is a portable 3D ultrasound imaging device designed to assist healthcare providers in identifying the proper vascular access points on the skin for patients with arteriovenous fistulas or grafts. It automates ultrasound imaging acquisition and displays live coronal plane images to guide clinicians during cannulation, improving accuracy and ease of use during the procedure.

The OcuMet Beacon is a scanning LED-based ophthalmoscope that captures detailed black and white infrared and autofluorescence images of the human retina. It helps eye care clinicians by providing high-quality retinal images to assist in diagnosis and management of eye conditions, supporting clinical decisions as an adjunctive imaging modality.

The ULTRA 1040 is a portable X-ray device designed for use by trained physicians or technicians to capture X-ray images of patients' extremities. It allows for flexible diagnostic imaging outside traditional settings, helping clinicians assess bone and joint conditions conveniently. It supports use with an X-ray detector and image processing software for image acquisition and processing.

The Wireless/Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited are digital imaging devices used with specialized software to capture and process X-ray images of all body parts for general radiographic applications. They convert X-rays into high-quality digital images, aiding radiologists in diagnosis by replacing traditional film-based systems.

The FLUOBEAM LX and FLUOBEAM LM are surgical imaging systems that use near infrared fluorescence to help surgeons visualize blood vessels, tissue perfusion, parathyroid glands, lymphatic vessels, and tissues that have absorbed specific dyes during surgery. By enhancing real-time images of tissues, these devices assist clinicians in making precise assessments during complex surgeries, improving patient outcomes.

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 Cornaris Intravascular Imaging System (P80-E and Mobile-E) with the LumenCross Imaging Catheter (F2) is an advanced intravascular imaging system designed to help clinicians visualize coronary arteries during transluminal interventional procedures. It uses optical coherence tomography technology to provide high-resolution images of the inside of blood vessels, aiding in diagnosis and treatment planning for patients with coronary artery conditions. The system enhances the ability to assess blood vessels safely and effectively, improving patient outcomes.

The FUJIFILM Processor EP-8000 and Endoscope Model EG-860R form a combined endoscopic video imaging system used in gastroenterology. The EP-8000 processor provides illumination with LED light sources and advanced image processing techniques to enhance visualization, while the EG-860R endoscope enables detailed examination and endoscopic treatment of the upper digestive tract. This system assists clinicians in diagnosing and treating conditions in the esophagus, stomach, and duodenum by delivering high-quality images and supporting multiple enhanced imaging modes.

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.