FDA Radiology AI Devices

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.

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.

Bonelogic is a software used by orthopedic healthcare professionals to assist in diagnosis and surgical planning of foot and ankle conditions using CT scan data. It provides semi-automatic segmentation of bones, creates 3D models, and offers measurement tools to support clinical decision-making and treatment planning.

Ceevra Reveal 3+ is a software medical imaging system that processes CT and MRI scans to generate detailed three-dimensional images. It uses machine learning algorithms to assist clinicians in segmenting and visualizing normal anatomy to support preoperative surgical planning and intraoperative display. This helps healthcare professionals better review, analyze, and plan treatment by interacting with 3D images on computers, mobile devices, or VR headsets.

The EPIQ Series Diagnostic Ultrasound System by Philips is a diagnostic ultrasound imaging device that provides detailed ultrasound images and fluid flow analysis to assist clinicians in diagnosing a wide range of medical conditions across multiple body regions. It supports advanced modes such as transesophageal cardiac imaging and works in different clinical environments including hospitals and clinics. The system integrates with Philips EchoNavigator to aid in cardiovascular interventions by providing live ultrasound and X-ray guidance, enhancing the precision of treatments.