FDA Radiology AI Devices

Oncospace is a software tool designed to help radiation oncologists and dosimetrists plan cancer treatments more efficiently. It uses machine learning to predict dose objectives for organs at risk based on patient anatomy, assists in setting up treatment protocols, and integrates with treatment planning systems to optimize and review radiotherapy plans. This helps clinicians design safer and more effective radiation schedules for patients with cancers in various body regions.

OTOPLAN is software that helps otologists and neurotologists visualize, segment, and analyze medical images such as CT and MRI scans to assist in planning and assessing ear-related surgical procedures like cochlear implantation. It provides tools for 3D reconstruction, electrode visualization, and image fusion, enhancing surgical planning accuracy and patient outcomes.

Second Opinion Periapical Radiolucency Contours is an AI-based computer-aided detection software that helps dentists identify areas of periapical radiolucency in dental X-rays by outlining suspected regions with polygonal contours. It supports dental professionals by providing a second opinion when reviewing periapical radiographs, potentially improving detection accuracy and aiding clinical decisions.

cmAngio® (V1.6) is an AI-based software product designed to assist radiologists by automatically processing radiological images, potentially helping to detect or analyze vascular conditions.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced diagnostic ultrasound imaging systems used in various clinical settings, including hospitals and clinics. They provide imaging and fluid flow analysis of multiple body regions through modes like B Mode, Doppler, and Harmonic Imaging, helping clinicians diagnose a wide range of conditions. A new Remote Software Management feature enhances workflow by allowing remote software upgrades and maintenance, improving system availability and usability without hardware changes.

NEAT 001 is a software medical device that automatically analyzes EEG data obtained during sleep studies to detect different stages of sleep according to established sleep medicine guidelines. It helps clinicians by providing automated scoring and visualization of sleep stages, improving the efficiency and consistency of sleep evaluations in adult patients.

syngo.CT LVO Detection is an AI-powered post-processing software that analyzes CT angiography images of the brain to help clinicians prioritize cases by detecting suspected large vessel occlusions in specific brain vessels. It aids in triage but is not used for standalone diagnosis or altering images, thereby assisting medical professionals in managing stroke patients more efficiently.

Vitrea CT VScore is a software application designed to aid medical professionals in visualizing, segmenting, and quantifying calcified lesions in ECG-gated cardiac CT images of patients aged 30 years or older. It provides calcium scoring and generates detailed reports to assist clinicians in cardiac imaging assessment.

autoSCORE V2.0 is an AI-based software that helps medical professionals review EEG recordings by identifying and classifying sections indicating brain abnormalities such as epileptiform and non-epileptiform activities. It assists neurologists by marking likely abnormal EEG segments, providing probabilities for specific abnormality types, thereby enhancing the efficiency and accuracy of EEG interpretation without replacing clinical judgment.

BunkerHill BMD is an AI-based software tool designed to estimate bone mineral density from existing CT scans of the spine in adults aged 30 and over. It helps clinicians identify low bone density without requiring dedicated bone densitometry scans, supporting retrospective assessment and aiding clinical decision-making.