FDA Radiology AI Devices

Precise Position is an AI-enabled accessory for Philips Incisive CT systems that assists technologists in accurately positioning patients before CT scans. It uses a ceiling-mounted camera to detect patient orientation, determine the scan range, and automatically center the patient's anatomy. This reduces positioning time and enhances accuracy for head, chest, abdomen, and pelvic CT imaging, ultimately improving imaging workflow and patient comfort.

EnsoSleep is a software medical device designed to analyze previously recorded physiological signals from sleep studies to automatically score sleep stages, detect arousals, leg movements, and various types of sleep-disordered breathing events. It supports both adult and pediatric patients and can be used for in-lab or home sleep tests. EnsoSleep assists clinicians by providing automated detection and scoring of events, which are then verified and can be edited by qualified clinicians to aid in diagnosing sleep disorders.

Transpara 1.7.0 is an AI software tool designed to assist physicians in interpreting breast imaging exams such as digital mammography and tomosynthesis. It uses deep learning algorithms to detect suspicious calcifications and soft tissue lesions, scoring their likelihood of malignancy to aid diagnosis and improve workflow. It processes images to highlight abnormal areas and provides exam-level cancer likelihood scores, supporting better identification of breast cancer indicators.

The Zio ECG Utilization Software (ZEUS) System is a software platform that processes and analyzes long-term continuous ECG data collected from compatible cardiac monitoring devices. It helps clinicians by automatically detecting and reporting cardiac arrhythmias and other relevant heart rhythm information, assisting in the diagnosis and management of cardiac conditions.

Overjet Dental Assist is a software designed to assist dental professionals by semi-automatically measuring bone levels on dental bitewing and periapical radiographs. It helps by automating the measurement process to support diagnosis and treatment planning but is not intended to replace full patient evaluation or diagnosis by professionals.

MEDO-Thyroid is a cloud-based software that uses machine learning to help radiologists evaluate ultrasound images of the thyroid. It assists in measuring thyroid lobes and nodules, supports diagnosis by providing volume measurements and TI-RADS classification, and generates reports, improving the efficiency and accuracy of thyroid image assessment for adult patients.

Eclipse II with Smart Noise Cancellation is software that improves digital X-ray images by reducing noise using advanced AI technology. It enhances images acquired with digital radiography systems, helping radiologists see clearer images for better diagnosis of adult and pediatric patients, excluding mammography.

The syngo.CT Lung CAD by Siemens Healthcare GmbH is a software tool designed to assist radiologists in detecting solid and subsolid lung nodules on chest CT scans. It uses advanced AI algorithms based on convolutional neural networks to highlight suspicious areas, reducing the chance of missed nodules. The software integrates with existing medical imaging platforms, improving clinicians' efficiency and accuracy in lung nodule detection, a critical task in lung cancer screening and diagnosis.

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

ProFound AI Software V3.0 is an AI-based medical imaging software that aids radiologists by detecting and highlighting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It provides confidence scores that help clinicians identify potentially malignant findings more quickly and accurately during breast cancer screening and diagnosis.