FDA Radiology AI Devices

DASI Dimensions (V1.0) is a clinical decision support software that processes multiphase CTA chest images to generate automated measurements of cardiovascular structures. It helps cardiologists and radiologists by providing detailed images and numerical data to support planning for aortic valve replacement procedures, improving accuracy and efficiency of pre-operative assessments.

VEA Align is a cloud-based software developed by EOS imaging that uses 2D X-ray images acquired from EOS imaging systems to assist healthcare professionals in assessing global alignment in orthopedic patients. It applies machine learning algorithms to automatically place anatomical landmarks on images, helping clinicians analyze spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements. It supports both pediatric and adult patients and enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.

The Butterfly iQ3 Ultrasound System is a portable, hand-held ultrasound device used by trained healthcare professionals to capture diagnostic ultrasound images and measurements across multiple clinical areas such as cardiac, abdominal, lung, musculoskeletal, fetal/obstetric, and more. It offers various imaging modes and supports professional use in diverse healthcare environments, helping clinicians visualize anatomical structures and fluids for adult and pediatric patients.

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.

qXR-LN is an AI-based software device that analyzes frontal chest X-rays to detect and mark suspected lung nodules between 6 and 30 mm. It acts as a second reader to assist physicians like radiologists and pulmonologists, providing adjunctive information to improve detection accuracy without substituting the original image or clinical judgment.

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.

MAGNETOM Sola and MAGNETOM Altea are advanced MRI systems designed to produce high-quality transverse, sagittal, coronal, and oblique cross-sectional images. They include AI-powered features such as Deep Resolve Boost and Deep Resolve Sharp for enhanced image reconstruction, improving image quality and diagnostic accuracy. These systems assist clinicians in diagnosis by providing improved visualization of internal structures and functions across the head, body, and extremities, and can also be used during MR-guided interventional procedures.

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.

MAGNETOM Cima.X is an advanced magnetic resonance imaging (MRI) system designed to produce detailed images and spectroscopic data of the head, body, and extremities. It incorporates new and modified hardware and software features including deep learning-based reconstruction methods to enhance image quality and speed, helping clinicians in diagnosis and interventional imaging procedures.