FDA Radiology AI Devices

The STAR Apollo Mapping System is a software tool designed to help physicians analyze detailed electrical and anatomical heart maps collected during cardiac procedures for atrial fibrillation. By processing data from mapping catheters and displaying key activation patterns in the atria, it provides supplementary information that may assist clinicians in identifying areas of irregular heart activation, although its clinical significance is not yet established.

Cina is an AI-powered software designed to assist radiologists by automatically analyzing head CT and CT angiography images to detect intracranial hemorrhage and large vessel occlusion. It provides notifications and preview images to help prioritize and triage cases, enhancing workflow efficiency and potentially enabling faster diagnosis and treatment without replacing standard diagnostic procedures.

The Avenda Health AI Prostate Cancer Planning Software is an AI-driven tool that assists physicians by segmenting prostate MR images, evaluating and quantifying lesions, and planning diagnostic or interventional procedures such as biopsies or tissue ablation. It provides a cancer probability map and confidence scores to help clinicians accurately characterize prostate cancer lesions, improving workflow efficiency and decision making in prostate cancer care.

The SIS System version 5.6.0 is a medical imaging software that helps surgeons, neurologists, and radiologists visualize specific brain structures in 3D to assist with planning neurological surgeries such as deep brain stimulation. It uses advanced image processing and machine learning techniques to create patient-specific anatomical models from MRI and CT images, improving precision during surgical interventions.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes frontal chest X-rays to detect and flag cases where an endotracheal tube (ETT) is improperly positioned relative to the carina. It assists hospital networks and trained specialists by prioritizing worklists to enable quicker review of potentially urgent cases. The software operates alongside standard care without altering original images, providing early alerts that help clinicians review and manage patient care more efficiently.

BoneMRI v1.4 is an image processing software that analyzes 3D gradient echo MRI scans to enhance visualization of bone structures in the pelvic and lumbar spine regions. It uses a convolutional neural network algorithm to generate images with improved bone contrast compared to surrounding soft tissue, helping clinicians better assess bone morphology and density without the need for CT scans. It is intended for use by radiologists and orthopedic surgeons to aid in image interpretation, but not for tumor diagnosis.

Syngo Dynamics (Version VA40F) is a software medical device from Siemens designed to assist healthcare professionals in reviewing and analyzing medical images for disease detection and patient management. It supports multiple imaging modalities including ultrasound, x-ray angiography, CT, MR, nuclear medicine, and others, with applications primarily focused on cardiology, vascular, and fetal imaging. The software offers advanced image processing tools and semi-automated measurement capabilities such as left ventricular ejection fraction estimation, helping clinicians interpret complex imaging data efficiently within healthcare networks.

AVIEW RT ACS is a software solution developed by Coreline Soft Co., Ltd. that uses deep learning AI to automatically segment organs and generate contours from CT scans. It is intended to assist clinicians, particularly in radiation oncology, by providing initial organ contours for treatment planning, saving time and improving accuracy.

AEYE-DS is an AI-powered retinal diagnostic software that helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes using fundus images from a Topcon NW400 camera. It improves screening efficiency by analyzing images to identify disease presence, helping to guide timely patient care.

The EFAI ChestSuite XR Pneumothorax Assessment System is an AI-powered software tool that helps clinicians prioritize chest X-ray cases suspected of pneumothorax. It uses deep learning to analyze posteroanterior chest X-rays and provides case-level notifications in the existing PACS/workstation workflow, facilitating faster identification and assessment of patients who may have pneumothorax. It supports clinical decision-making by aiding in triage but is not intended for stand-alone diagnosis.