FDA Radiology AI Devices

The Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems by Edan Instruments are advanced ultrasound imaging devices used by clinicians for a wide range of clinical applications including abdominal, cardiac, musculoskeletal, and vascular imaging among others. These systems support multiple imaging modes such as B mode, Doppler, harmonic imaging, elastography, and contrast imaging, aiding healthcare professionals in acquiring and interpreting ultrasound data to diagnose and monitor patient conditions effectively.

The NUSONO Handheld Ultrasound Scanner is a portable, software-driven ultrasound imaging system that interfaces wirelessly with mobile devices to provide high-resolution diagnostic imaging in various clinical applications. It supports multiple imaging modes, including B-mode, M-mode, Color Doppler, and Power Doppler, enabling healthcare professionals to effectively diagnose conditions across fetal, abdominal, pediatric, urology, gynecology, cardiac, and lung areas. By integrating with smartphones and tablets, it offers flexible, real-time imaging solutions for use in clinics, hospitals, and point-of-care settings, enhancing diagnostic confidence and accessibility.

The EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is software that assists medical professionals by automatically analyzing chest X-ray images to detect misplaced endotracheal tubes. It uses deep learning to flag suspicious cases and prioritize them in the workflow, helping radiologists review these urgent cases more quickly. The software provides alerts when the tube tip is positioned too high, too low, or incorrectly and supports clinical decision-making by improving triage efficiency.

Brainomix 360 e-Lung is a software tool designed to assist physicians by providing automated, quantitative analysis of chest CT images. It offers 3D segmentation, volumetric measurements, and density evaluations of lung tissue to support diagnosis and longitudinal assessment of lung diseases, enhancing workflow efficiency and accuracy in radiological interpretation of CT thoracic scans.

AVIEW CAC is a software tool designed for healthcare professionals to analyze non-contrast, non-gated Chest CT scans and quantitatively evaluate calcified plaques in coronary arteries. It automatically calculates the Agatston score, segments and evaluates the coronary arteries, and provides risk stratification based on calcium score, gender, and age. It facilitates access to CT data on various platforms, helping clinicians assess coronary artery disease risk using existing CT images.

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.

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.

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.