FDA Radiology AI Devices

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.

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.

AI-Rad Companion (Musculoskeletal) is an AI-powered software that analyzes previously acquired CT images to assist radiologists and physicians in evaluating musculoskeletal diseases. It segments, labels vertebrae, measures vertebral heights, and computes mean Hounsfield values to provide detailed quantitative and qualitative analysis, improving assessment and workflow efficiency for clinicians.

AI-Rad Companion Organs RT is a software product by Siemens that uses deep learning to automatically contour organs at risk on CT imaging data. The output contours help radiation oncologists plan external beam radiation therapy by providing accurate anatomical structures for treatment planning. The software processes CT scans, generates contour data in DICOM RTSTRUCT format, and integrates with treatment planning systems to improve clinician workflow and efficiency in radiation therapy preparation.

NS-HGlio is a software tool that assists clinicians in analyzing MRI images of patients with high-grade brain gliomas by automatically labeling and measuring tumor regions. It supports doctors by providing volumetric data and visual overlays to help monitor tumor progression or treatment response, but it is not intended for primary diagnosis.

The syngo.via RT Image Suite by Siemens is advanced software that helps clinicians visualize and manipulate 3D and 4D medical images from multiple modalities like CT, MRI, PET, and CBCT. It supports contouring tumors and organs at risk, image registration, and creating simple treatment plans, aiding radiation therapy preparation. The software includes AI-based deep learning for lung lobe segmentation to calculate lung ventilation, improving the accuracy and efficiency of radiation therapy planning.

LiverMultiScan v5 is software that helps clinicians assess liver health by analyzing MRI scans to generate detailed images and quantitative maps of liver tissue properties such as fat content, iron concentration, and T1 relaxation times. It aids doctors in diagnosis by providing automated liver segmentation and measurements that enhance non-invasive liver assessment.

AutoContour RADAC V2 is a software tool that helps radiation treatment planners by automatically outlining anatomical structures in CT and MR images to assist in radiation therapy treatment planning. It uses machine learning models trained on large datasets to generate these contours and allows clinicians to review and modify them before exporting for use in treatment.

The HS40 Diagnostic Ultrasound System by Samsung Medison is a general-purpose, mobile ultrasound device designed to acquire and display ultrasound images and analyze body fluids. It supports multiple imaging modes including 2D, 3D/4D, Doppler, and elastography, and incorporates AI-based features such as NerveTrack for nerve detection and UterineAssist for uterus segmentations to aid clinicians in diagnosis and procedural guidance.

TeraRecon Neuro is an AI-powered image processing software that analyzes brain perfusion data from CT or MRI scans. It helps healthcare professionals visualize blood flow and other key parameters in the brain to aid diagnosis, treatment planning, and post-treatment evaluation by providing detailed parametric maps and 3D visualizations of brain tissues and vessels.