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.

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.

Jazz is a semi-automatic medical image processing software designed to assist physicians in labeling, visualizing, and measuring volumes of brain structures from MRI scans. It is intended for use with patients diagnosed with multiple sclerosis or brain metastases, enabling physicians to review, correct, and confirm segmentations before generating radiological reports, thereby supporting clinical workflows for brain imaging analysis.

NEUROShield is a software tool that automatically labels, visualizes, and measures the volume of the hippocampus brain structure using 3D MRI images. It uses AI deep learning models to assist neurologists and neuroradiologists by providing fast, accurate volumetric analysis, helping in clinical decision-making and research.

The CARTO™ 3 EP Navigation System Software V8.0 is a catheter-based cardiac mapping system that helps clinicians map the electrical activity and anatomy of the heart in 3D during electrophysiological procedures. Using specialized catheters and advanced mapping technologies including machine learning algorithms, it improves visualization and identification of complex heart signals to guide interventions and improve procedural outcomes.

VisAble.IO is a software tool that helps doctors plan and confirm liver ablation procedures using CT images. It provides features like segmentation of liver structures, virtual placement of ablation needles, and analysis of ablation zones to support clinicians during treatment. It is designed to improve the accuracy and efficiency of liver ablation therapy planning and evaluation in clinical settings.

AIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.

ANDI is a software tool that processes diffusion-weighted MRI brain scans to create 3D maps of white matter tracts. It helps neurologists and radiologists by providing detailed visualization and measurements of brain white matter structures, serving as an adjunct tool for patient assessment without making diagnoses.

OptimMRI is a software tool that helps medical professionals analyze pre-operative brain MRI images by generating 3D annotated models. It supports neurosurgical planning by localizing key brain regions, helping doctors visualize and plan treatments more precisely.

uOmnispace is a medical image post-processing software solution that supports viewing, manipulation, annotation, and communication of various medical images from multiple modalities including CT, MRI, PET and DR. It includes AI-based segmentation tools like rib segmentation, and enables remote multi-user access and integration with medical imaging systems. It helps clinicians efficiently analyze and report on diagnostic images.