FDA Radiology AI Devices

Brainomix 360 e-ASPECTS is an AI-based software that analyzes non-contrast CT brain scans to help clinicians assess ischemic brain tissue injury and calculate an ASPECTS score, which reflects the extent of stroke-related brain damage. It uses automated image processing and machine learning to highlight affected brain regions, providing decision support for stroke diagnosis and treatment.

BriefCase-Triage is an AI-based radiological software designed to assist clinicians by automatically analyzing contrast-enhanced CT images including the lungs to detect suspected cases of incidental pulmonary embolism. It notifies users with preview images for triage and prioritization, enabling faster attention to critical cases without replacing standard diagnostic workflows.

Green X 21 (PHT-90CHO) is an advanced 6-in-1 digital dental X-ray system that combines multiple imaging modalities including panoramic, cephalometric, and 3D CT scans for diagnostic details of dento-maxillofacial, sinus, TMJ, and ENT regions. It helps clinicians by providing comprehensive imaging from one device to improve diagnosis and treatment planning, especially for adult and pediatric dental and ENT patients.

ICS Dizcovery (1091) is a portable video-oculography system designed as goggles with built-in cameras and motion sensors to track eye and head movements simultaneously. It is used to assess vestibular-ocular reflex and nystagmus in patients experiencing dizziness, vertigo, or balance disorders. The system connects to software that analyzes the collected eye movement data to aid clinicians in diagnosing vestibular conditions.

The Penumbra System (Reperfusion Catheter RED 72) is a catheter-based device designed to remove blood clots in the brain's large vessels to treat acute ischemic stroke. It uses aspiration to restore blood flow in blocked intracranial vessels during neurointerventional procedures, guided by fluoroscopy. This device helps clinicians revascularize patients who are ineligible or have failed thrombolytic drug therapy, improving stroke treatment outcomes.

AspenView is a software designed to assist radiologists and radiology technicians in annotating, processing, and managing general radiographic X-ray images. It supports standard medical image formats and provides functions such as image stitching, storage, and transmission, helping clinicians handle and review X-ray images efficiently.

The Etiometry Platform is a software solution designed for use in intensive care settings to help healthcare professionals monitor and assess cardiovascular and respiratory conditions in adult, pediatric, and neonatal patients. It collects real-time physiological and laboratory data remotely from various bedside devices, displays this data, and calculates risk indices like oxygen delivery adequacy and ventilation status. This assists clinicians in timely clinical decision-making without requiring new hardware.

The NAEOTOM Alpha series by Siemens is a computed tomography (CT) scanner system that produces detailed cross-sectional images using X-rays. These images aid clinicians in diagnosis, treatment, radiation therapy planning, and interventions, including low-dose lung cancer screening for high-risk populations. The system uses advanced software for image reconstruction and supports various post-processing applications to deliver clear and precise imaging for multiple clinical uses.

SubtleHD (1.x) is an AI-based image processing software designed to enhance MRI images from any body part. It improves image quality by reducing noise and increasing sharpness, helping radiologists obtain clearer images without changing the original scan process. This facilitates improved diagnostic confidence and visualization of anatomical structures.

SureWave Elastography is an accessory device for Siemens MRI systems that generates shear wave vibrations during MRI scans to create images showing tissue stiffness. This advanced imaging helps physicians diagnose tissue abnormalities by providing detailed stiffness maps alongside traditional MRI images.