FDA Radiology AI Devices

MySegmenter (v2.0.0) is a medical imaging software that converts CT and MRI scans into 3D anatomical models for surgical planning and educational use, specifically in orthopedic and craniomaxillofacial cases. It helps clinicians visualize and prepare for surgeries by creating accurate, patient-specific 3D models, though it is not intended for use in the operating room.

The Nanox.ARC X is a stationary digital tomosynthesis X-ray system designed to create detailed tomographic images of various body parts, including musculoskeletal, pulmonary, abdominal, and sinus regions. It complements traditional X-ray imaging by producing slice images that reduce the overlap of structures, enhancing diagnostic clarity. The system operates multiple low-dose X-ray sources sequentially and reconstructs images either locally or via a secure cloud, aiding clinicians in more precise diagnosis and patient care in adult patients under professional healthcare settings.

The SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is a CT X-ray system that produces cross-sectional images of the body, particularly the cardiovascular and thoracic regions. It includes protocols for low dose CT scans aimed at lung cancer screening, ensuring minimal radiation exposure while maintaining image quality. This device assists clinicians in diagnosing lung cancer and planning related therapies, utilizing advanced image reconstruction algorithms and adaptable scan techniques for patients of various sizes.

The Atlas Stim Headbox by Neuralynx, Inc. is a medical device intended for cortical or intracranial stimulation during EEG examinations, such as stereo EEG (SEEG). It works as an accessory to the ATLAS Neurophysiology System, enabling controlled electrical stimulation of the brain using third-party electrodes and recording the brain's electrical responses. This device assists neurosurgeons and neurologists in mapping brain function, especially in complex cases requiring precise neural stimulation.

Merge Universal Viewer (MUV) is a software application that provides healthcare professionals internet access to view, analyze, and share medical images from multiple imaging modalities. It supports diagnostic workflows by enabling display and manipulation of radiological images, and can output digital files for 3D printing. The viewer facilitates image review, reporting, and data sharing, thus improving accessibility and efficiency in radiology departments.

The Cornaris Intravascular Imaging System (P80-E and Mobile-E) with the LumenCross Imaging Catheter (F2) is an advanced intravascular imaging system designed to help clinicians visualize coronary arteries during transluminal interventional procedures. It uses optical coherence tomography technology to provide high-resolution images of the inside of blood vessels, aiding in diagnosis and treatment planning for patients with coronary artery conditions. The system enhances the ability to assess blood vessels safely and effectively, improving patient outcomes.

The FUJIFILM Processor EP-8000 and Endoscope Model EG-860R form a combined endoscopic video imaging system used in gastroenterology. The EP-8000 processor provides illumination with LED light sources and advanced image processing techniques to enhance visualization, while the EG-860R endoscope enables detailed examination and endoscopic treatment of the upper digestive tract. This system assists clinicians in diagnosing and treating conditions in the esophagus, stomach, and duodenum by delivering high-quality images and supporting multiple enhanced imaging modes.

GBrain MRI is a software tool that automatically segments, quantifies, and reports the volume of signal hyperintensities in brain MR FLAIR images. It helps radiologists by providing quantitative measurements to support the evaluation of brain MRI scans, enhancing clinical assessment without replacing the physician's judgment.

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.