FDA Radiology AI Devices

The UNiD™ Spine Analyzer by Medicrea International is a software tool designed to automatically process radiological images of the spine. It helps clinicians by providing detailed analysis of spinal images, which facilitates diagnosis and treatment planning for spinal conditions.

Voxel Dosimetry is a software tool used in nuclear medicine to calculate the absorbed radiation dose distribution within a patient's body at the small voxel level and for specific organs. It uses deep learning based semi-automatic segmentation and non-rigid image registration to analyze images post-radionuclide therapy, providing clinicians with detailed dose mapping to assist in treatment planning and evaluation.

Synapse PACS (7.5) by FUJIFILM Healthcare Americas Corporation is a web-based software application designed to manage, display, and process medical images from various modalities. It provides advanced tools such as measurements, regional segmentation, 3D volume rendering, fusion, and structured report generation to support clinicians like radiologists and cardiologists in reading, interpreting, and planning patient care efficiently.

EchoConfidence (USA) is an AI-powered software that helps clinicians analyze transthoracic echocardiogram images. It automatically classifies views, segments cardiac structures, measures cardiac function, and performs Doppler assessments, improving the efficiency and accuracy of cardiac image interpretation for adults and adolescents.

RT Elements 4.5 is a computer-based software suite designed to assist clinicians in planning radiation treatments for brain, spine, and extracranial lesions. It supports stereotactic and conformal radiation therapy by providing optimized treatment plans, dose reviews, and AI-based tumor segmentation, helping improve accuracy and efficiency in patient treatment.

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.

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.

Viz Subdural+ is an AI-powered software that automatically analyzes head CT scans to measure subdural collections and midline shift. It helps clinicians by providing automated volume and width measurements of subdural collections, improving efficiency and accuracy in brain injury assessment.

Opulus™ Lymphoma Precision is an AI-powered software tool designed to help physicians analyze whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas. It automatically segments and visualizes lymphoma lesions and calculates the total metabolic tumor volume. This supports physicians by reducing the manual workload and assisting in more efficient interpretation of PET/CT images, although final decisions remain with the radiologist.

The Voluson™ Performance 16 and Voluson™ Performance 18 are advanced diagnostic ultrasound systems designed for use by trained healthcare professionals to image, measure, display, and analyze human body structures and fluids. These systems support a wide range of clinical applications including fetal/obstetrics, abdominal, pediatric, small organ, cardiac, vascular, musculoskeletal, and more. They provide real-time 3D/4D imaging, various Doppler modes, elastography, and have integrated AI features to assist in analysis. These systems enhance clinicians' ability to perform ultrasound examinations efficiently and with high image quality, aiding patient diagnosis and care.