FDA Radiology AI Devices

Annalise Enterprise is an artificial intelligence software designed to analyze chest X-ray images to detect several critical findings such as pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fractures. It supports clinicians by prioritizing studies containing these suspected findings to streamline and accelerate patient care workflow, aiding in triage and worklist management.

The Dynamis Robotic Surgical System is a robotic platform designed to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spine surgeries. It uses real-time tracking and intraoperative CT images to navigate and position surgical tools accurately, especially for placing spinal pedicle screws in the thoracic, lumbar, and sacral regions. This helps improve surgical accuracy and patient safety.

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 eHertz Functional Series Diagnostic Ultrasound System by eSonic Technology is a portable ultrasound imaging device designed for general diagnostic use across adults, pregnant women, and pediatric patients. It supports multiple imaging modes including B-mode, Doppler, and elastography among others, enabling healthcare professionals to visualize and analyze the human body and fluid for various exams such as fetal, abdominal, cardiac, and musculoskeletal. This system enhances image quality through features like micro blood flow imaging and image optimization, aiding clinicians in making more accurate assessments.

MySpine WebPlanner is a web-based surgical preoperative planning software that assists orthopedic and neurosurgeons by allowing them to view, store, measure radiological images, and plan surgical placement of spinal fixation and fusion devices. It supports surgeons in preparing surgical plans by providing detailed imaging and implant positioning information, helping improve clinical decision-making before spinal surgery.

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.

VersaViewer is a medical image management and processing system software developed by GE Medical Systems SCS. It supports 2D, 3D, and 4D medical images from multiple modalities and provides customizable layouts for multimodality review. It offers measurement, annotation, segmentation tools, and advanced visualization options to assist trained healthcare professionals in diagnostic workflows. The software includes an optional One View feature for automated multi-organ segmentation using deep learning, enhancing radiologists' efficiency in interpreting spectral CT exams. It is intended to assist physicians in diagnosis, though physicians retain final decision-making responsibility.

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 CLARUS 700 is an advanced ophthalmic imaging device designed to capture high-resolution images of the retina and ocular structures to aid clinicians in diagnosing and monitoring eye diseases. It supports true color, autofluorescence, fluorescein angiography, and indocyanine green angiography imaging modes over wide fields of view. The device incorporates AI algorithms for optic nerve head detection to improve image alignment and provides tools for image annotation and measurement, facilitating comprehensive eye health analysis.