FDA Radiology AI Devices

The VitalSigns 1-Lead Holter (VSH101) is a wireless, ambulatory ECG monitoring device that records, transmits, and stores single-channel ECG data via Bluetooth to a compatible mobile app. It helps healthcare professionals and individuals with cardiac conditions by providing supplementary ECG information for patient monitoring.

MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are advanced 1.5T MRI systems by Siemens that produce high-resolution images of the head, body, or extremities, using MR technology and optional local coils. Equipped with AI-powered software features such as Deep Resolve for image enhancement and AutoMate Cardiac for cardiac imaging automation, these devices help clinicians obtain detailed diagnostic images efficiently and safely, facilitating diagnosis and interventional procedures.

Methinks NCCT Stroke is an AI-based software designed to assist clinicians by automatically analyzing non-contrast head CT scans to detect signs of intracranial hemorrhage and large vessel occlusion. It prioritizes and notifies suspected positive cases to improve workflow efficiency and triage in stroke care, offering rapid alerts that support clinical decision-making without replacing standard diagnostic procedures.

The MAGNETOM Avanto Fit, MAGNETOM Skyra Fit, MAGNETOM Sola Fit, and MAGNETOM Viato.Mobile are MRI systems designed to produce detailed diagnostic images and spectra of the head, body, and extremities. They include advanced AI-based features such as Deep Resolve Boost and Deep Resolve Sharp to enhance image quality and speed, aiding radiologists in diagnosis and treatment planning.

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.

The Accuro® 3S Needle Guide Kit by Rivanna Medical, Inc. is a sterile, disposable accessory designed for use with the Accuro® 3S ultrasound imaging system. It helps healthcare professionals accurately align needles with the ultrasound imaging plane during procedures, stabilizing the needle guide position and isolating the needle insertion site from contaminants. This aids in precise anatomical targeting and improved procedural safety.

Brainlab Elements (7.0) is a suite of medical imaging software applications that aid clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for image fusion (aligning different imaging datasets), angiographic image registration, contouring (outlining anatomical structures), fibertracking (visualizing brain white matter tracts from diffusion imaging), and functional MRI mapping. The device supports precise treatment planning by combining and analyzing various imaging data, helping clinicians visualize critical anatomical and functional areas without being used for diagnostic purposes.

The FUJIFILM Endoscope Model EB-710P is a flexible bronchoscope designed to observe, diagnose, and treat the trachea and bronchus. It works with the FUJIFILM Processor EP-8000, which provides illumination, processes visual signals from the endoscope, and enables image recording. This combination aids clinicians in examining airways more effectively under physician management.

Aurora is a medical imaging system that combines nuclear medicine (SPECT) and CT imaging to help healthcare professionals detect and evaluate diseases including cardiovascular, neurological disorders, and cancer. It provides enhanced imaging through various scanning modes, real-time processing features including deep-learning based automatic kidney segmentation, and supports therapy planning and monitoring.

Second Opinion® CS is a computer-aided detection software designed to help dental health professionals detect and segment caries in radiographs of permanent teeth. Using AI and machine learning, it highlights potential caries lesions and provides detailed analysis on their overlap with tooth structures, improving diagnostic accuracy and assisting clinicians in reviewing dental images.