FDA Radiology AI Devices

Viz HDS by Viz.ai is an AI-powered software that automatically labels, visualizes, and measures critical brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift on non-contrast head CT scans. This automation helps radiologists quickly and accurately assess brain abnormalities by providing detailed volumetric data and annotated images, improving workflow and diagnostic efficiency.

CEPHX is a software tool designed for orthodontists that uses AI to analyze cephalometric x-ray images. It automatically identifies important anatomical landmarks on 2D x-rays, aiding in diagnosis, treatment planning, and patient consultation for individuals over 14 years old. This helps clinicians effectively monitor and simulate orthodontic treatment progress.

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.

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.

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.

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.

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.