FDA Radiology AI Devices

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.

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 Low Ejection Fraction AI-ECG Algorithm by Anumana, Inc. is a software tool that analyzes 12-lead ECG signals using AI to aid in screening for patients with low left ventricular ejection fraction (≤ 40%). It helps clinicians identify adults at risk of heart failure to decide if further cardiac evaluation is needed. It works quickly on routine ECGs and does not replace diagnostic imaging but supports clinical judgment.

Volta AF-Xplorer is a medical software device that helps doctors analyze and annotate electrical signals from the heart in real-time. It uses machine learning to detect areas in the atria that exhibit abnormal electrical patterns during atrial fibrillation or tachycardia, supporting catheter ablation procedures. This software integrates with cardiac mapping systems to improve the precision and efficiency of cardiac electrophysiology interventions.

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-based software tool that assists clinicians by analyzing non-contrast brain CT scans to detect signs of vasogenic edema. It helps prioritize cases with suspected findings for earlier review, improving workflow efficiency in medical imaging departments.

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.

qXR-CTR is an AI-powered software that helps physicians automatically measure the cardiothoracic ratio—the size of the heart relative to the chest—using chest X-ray images. It analyzes images to provide quick, accurate measurements that support clinical decision-making, making the process more efficient for healthcare providers.