FDA Radiology AI Devices

The EFAI NeuroSuite CT ICH Assessment System by Ever Fortune.AI is AI-based software that analyzes adult non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It helps radiologists prioritize urgent cases by sending triage notifications to their imaging workstations, enabling faster clinical assessment. This tool supports but does not replace clinician review.

VUNO Med-DeepBrain is an AI-powered medical software designed to automatically label, quantify, and visualize brain structures and lesions from MR images. It helps clinicians by automating manual brain segmentation processes, providing volumetric data along with visual color maps and reports, facilitating brain diagnosis and tracking over time in a clinical environment.

The Samsung V8/H8, V7/H7, and V6/H6 Diagnostic Ultrasound Systems are advanced ultrasound machines designed to obtain and analyze ultrasound images and body fluids. They support a wide range of clinical applications such as fetal/obstetrics, abdominal, gynecology, cardiac, musculoskeletal, and vascular imaging. The systems offer multiple imaging modes including 2D, Doppler, ElastoScan, and 3D/4D modes, helping healthcare professionals diagnose patients more effectively. An AI-based feature called NerveTrack provides segmentation of nerves during ultrasound examinations, aiding in procedures involving nerve identification.

The uMI Panorama is a diagnostic imaging system combining PET and CT scans to provide both functional and anatomical information of the body. It helps healthcare professionals detect and evaluate diseases in oncology, cardiology, and neurology by offering fused metabolic and anatomical images. The device includes AI-based software updates to improve image reconstruction and analysis, enhancing diagnostic accuracy and patient management.

Lung-CAD is an AI-based software designed to assist physicians by analyzing chest X-ray images and identifying regions of lung hyperinflation. It highlights these regions with boxes on the X-ray images to support concurrent reading, improving detection accuracy without replacing clinical diagnosis.

HipCheck is a software tool used during hip arthroscopy surgeries that helps surgeons measure the alpha angle related to femoroacetabular impingement (FAI). It processes X-ray images taken during surgery and overlays virtual measurement tools on these images to support clinical decision-making. It also includes a patient-specific report feature for preoperative planning using three-dimensional analyses and visualizations of the hip.

Brainomix 360 Triage LVO is an AI-powered software that analyzes CT angiogram images to detect suspected large vessel occlusions in the brain. It assists hospital clinicians by providing priority notifications and compressed image previews via a mobile app or web interface, helping specialists quickly identify and review critical cases in parallel with standard workflows. This tool supports faster triage but is not intended for diagnostic use on its own.

The OFIX MIS App is a mobile software application designed to help healthcare professionals view, store, and measure images to plan orthopedic surgeries, specifically for spinal implant procedures. It uses images captured via a mobile phone camera to assist in selecting the correct rod length for pedicle screw spinal systems, aiding surgeons in making precise implant placement decisions.

EFAI RTSUITE CT HCAP-Segmentation System is an AI-powered software tool designed to assist radiation oncology professionals by automatically outlining critical organs at risk on CT scans. It helps radiation therapists plan treatments more efficiently by providing initial organ contours that clinicians can review and adjust, improving workflow while ensuring safety and accuracy.

Annalise Enterprise CTB Triage Trauma is an AI software tool designed to analyze non-contrast brain CT scans and assist clinicians by prioritizing cases with features suggestive of mass effect. It integrates with image and order management systems to notify users for earlier review, improving workflow efficiency without replacing clinical decision-making.