FDA Radiology AI Devices

Rapid ASPECTS (v3) is a software tool designed to assist clinicians in evaluating brain CT images for early ischemic stroke. It automatically analyzes certain brain regions to generate an ASPECT Score, which helps characterize ischemic damage. This tool supports radiologists by providing standardized, AI-derived scores and annotated images, facilitating accurate and consistent stroke assessment to inform treatment decisions.

The SIGNA Champion is a 1.5 Tesla whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images quickly. It can image multiple body regions including the head, neck, spine, chest, abdomen, pelvis, joints, and more, using various scan planes and sequences to help physicians diagnose medical conditions. It supports advanced imaging techniques and uses standard MRI technology enhanced by new software and hardware components to improve image quality and workflow.

NemoScan is a dental implant and surgery planning software that reads CT or CBCT medical images to simulate and evaluate patient anatomy, plan implant placement, and design surgical guides. It helps dental professionals prepare customized surgical plans and export guides for manufacturing, improving precision and treatment outcomes.

Radify Triage is an AI-powered software that analyzes adult chest X-ray images to detect critical findings like pleural effusion and pneumothorax. It provides a notification within the PACS system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. It acts as a triage tool to flag suspicious cases but does not replace clinical decision-making.

Rapid (6.0) by iSchemaView, Inc. is a medical imaging software designed to process and analyze dynamic and functional imaging data from CT and MRI scans. It aids clinicians by providing advanced visualization, quantification, and analysis tools to help select acute stroke patients for treatment, enhancing diagnostic confidence and workflow efficiency.

Fibresolve is a software device that analyzes lung CT images using deep learning to identify patterns suggestive of idiopathic pulmonary fibrosis. It provides a binary output to assist clinicians in diagnosing fibrotic lung disease, serving as an adjunct tool in the diagnostic workflow especially before invasive testing, helping to improve early detection and referral for appropriate clinical discussion.

The Biograph VK10 is a combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner that provides fused images of both physiological function and anatomical structure. It assists healthcare providers in detecting, localizing, diagnosing, staging, and restaging various diseases such as cancer, cardiovascular and neurological disorders. The system supports single modality and combined PET/CT imaging and can aid in treatment planning and lung cancer screening in high-risk populations.

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.

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.