FDA Radiology AI Devices

The Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system that produces detailed cross-sectional images of the body or head. It incorporates AI-based reconstruction and machine learning technologies to enhance image quality and assist in planning scans, improving diagnostic accuracy and patient comfort.

MammoScreen 2.0 is an AI-based software tool designed to assist physicians by automatically analyzing standard screening mammograms including FFDM and DBT images. It marks suspicious soft tissue lesions or calcifications on breast images and provides a level of suspicion score to help radiologists improve detection and characterization of breast cancer findings. This tool acts as a concurrent reading aid to improve diagnostic accuracy but does not replace physician judgment.

OnQ Neuro is an automated software device designed to analyze neurological MRI images, specifically for brain tumors. It performs automatic segmentation and quantification of tumor volumes and diffusion-weighted imaging data, helping clinicians assess tumor progression and treatment response more efficiently by providing quantitative and graphical image data that can be integrated into clinical workflows.

Lunit INSIGHT MMG is an AI-powered computer-assisted detection and diagnosis software designed to help radiologists detect, localize, and characterize suspicious areas for breast cancer on mammograms. It works as an adjunct tool viewed after the initial physician read, providing visual marks and scores indicating the likelihood of malignancy to assist clinical decision-making and improve breast cancer detection during mammography screenings.

Soteria.AI is an image-intensified fluoroscopic x-ray system designed for use in a variety of radiographic and fluoroscopic applications including cardiac, vascular, general diagnostic, and interventional imaging. It helps reduce patient and operator radiation exposure by automatically providing a region of interest using AI technology, thereby improving safety during imaging procedures.

The Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) System by Hyperfine, Inc. is a portable MRI device designed to provide bedside imaging of the brain. It uses advanced deep learning for image reconstruction to reduce noise and blurring, enabling clinicians to view internal head structures more clearly. This system facilitates quicker and more accessible brain imaging in various care settings, aiding in diagnosis without the need to transport patients to traditional MRI suites.

The TEX20 and TEX10 series Diagnostic Ultrasound Systems by Shenzhen Mindray are versatile, software-controlled ultrasound machines designed for imaging adults, pregnant women, pediatric patients, and neonates. They support multiple imaging modes such as B-mode, Doppler (including Color, Power, Pulsed Wave), 3D imaging, elastography, and contrast imaging, helping clinicians visualize and measure anatomical structures and blood flow across a wide range of body areas including ophthalmic, fetal, abdominal, cardiac, and musculoskeletal exams. These systems enhance diagnostic confidence and efficiency for healthcare providers through advanced imaging features and AI-assisted tools such as Smart Nerve, which assists in visualizing nerve plexuses for guidance.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that wirelessly connects to smartphones or tablets to provide high-resolution, real-time diagnostic ultrasound images. It supports a wide range of clinical applications including cardiac, musculoskeletal, abdominal, fetal, and procedural guidance, helping healthcare professionals diagnose and monitor patients with ease and mobility.

Lunit INSIGHT CXR Triage is an AI-based software tool designed to analyze adult chest X-ray images and identify potentially critical lung conditions such as pleural effusion and pneumothorax. It flags suspicious cases in the radiology workflow, enabling radiologists to prioritize urgent cases more efficiently without altering the standard reading queue. It operates as a supportive notification system and is not intended for standalone clinical decision making.

Critical Care Suite with Endotracheal Tube Positioning AI Algorithm is a software tool that uses AI to automatically analyze frontal chest X-rays. It detects and localizes the position of an endotracheal tube and calculates the distance between the tube tip and the carina, providing clinicians with important information on tube placement to improve patient care.