FDA Radiology AI Devices

The Aplio i900, i800, and i700 Software V8.1 Diagnostic Ultrasound System by Canon Medical Systems is an advanced ultrasound imaging platform. It provides high-quality ultrasound images across a variety of clinical applications, including fetal, abdominal, cardiac, musculoskeletal, and more. The system includes advanced imaging modes such as Doppler and elastography, and new AI-based features like Left Atrial Appendage analysis to improve diagnostic accuracy and workflow efficiency.

LungQ v3.0.0 is a software tool that helps physicians analyze CT scans of the lungs by automatically segmenting lung structures, measuring lung volumes and densities, evaluating fissures, and generating reports. It supports diagnosis and monitoring of lung conditions by providing quantitative assessments from CT scans, streamlining clinical workflows.

TumorSight Viz is software developed by SimBioSys, Inc. that helps doctors visualize and analyze breast MRI images from patients with early-stage or locally advanced breast cancer. It supports dynamic MRI data evaluation by processing images to provide measurements, 3D renderings, and visualizations, which aid clinicians in planning treatment and assessing tumor characteristics. The system is cloud-based and used as a tool to support but not replace clinical decision-making.

ART-Plan is a radiotherapy treatment planning software that assists clinicians by visualizing and fusing multimodal medical images, automatically segmenting organs and lymph nodes using AI, generating synthetic CT images from MR and CBCT scans, computing dose distributions for radiation therapy, and aiding in treatment adaptation decisions. It enhances workflow efficiency and accuracy for trained professionals managing radiotherapy for cancer patients.

The HM70 EVO Diagnostic Ultrasound System by Samsung Medison is a mobile, software-controlled ultrasound imaging device that captures detailed 2D, 3D, and Doppler ultrasound images across a variety of clinical applications such as obstetrics, cardiology, musculoskeletal, and dermatology. It includes advanced AI-powered features for tasks like nerve detection and uterus assistance to improve diagnostic accuracy, supporting clinicians in making informed patient care decisions.

The United Orthopedic Knee Patient Specific Instrumentation by Enhatch, Inc. is a system that uses AI-powered software to process CT and X-ray images for 3D modeling and preoperative surgical planning of total knee arthroplasty. It includes patient-specific surgical guides to help orthopedic surgeons accurately position knee implants during surgery, improving precision and outcomes for patients without severe bone deformities.

uOmnispace.MI is an advanced software platform designed to help healthcare professionals view and analyze medical images from PET, CT, MR, and SPECT scans. It facilitates tasks such as image registration, lesion segmentation, and statistical analysis, supporting clinical workflows in oncology, neurology, and cardiology. The software integrates multiple applications including fusion imaging, dynamic analysis, brain scan quantification, and cardiac function analysis, thereby assisting clinicians in making timely and accurate diagnoses.

iQ-solutions is a software device designed to automatically identify, annotate, and measure specific brain structures on MRI scans. It helps clinicians by accelerating the quantification process, providing detailed volume analysis reports that support the assessment of brain anatomy and changes over time. The software improves workflow efficiency and consistency in brain MRI analysis.

StrokeViewer Perfusion is a software package designed to analyze dynamic brain CT perfusion scans to provide quantitative information about blood flow and volume in brain tissue. It aids medical professionals by visualizing perfusion maps and numerical data to assist in the evaluation of suspected ischemic stroke patients. The software supports clinicians by generating additional imaging data to inform diagnosis and treatment decisions without replacing clinical judgment.

QP-Brain® is an AI-powered medical imaging software that automatically segments and measures brain structures and white matter hyperintensities from MRI scans. It assists clinicians by providing volumetric data and comparison to normative references, supporting assessment of brain MRIs in adults and adolescents.