FDA Radiology AI Devices

The SOMATOM go. Platform and SOMATOM X. Platform CT scanners, produced by Siemens Medical Solutions USA, Inc., are advanced computed tomography systems designed to generate detailed cross-sectional images of patients. These devices aid healthcare professionals in diagnosis, treatment planning, and radiation therapy across a variety of clinical scenarios, including lung cancer screening. The systems feature a fan-beam CT technology, sophisticated software for image reconstruction and optional AI-assisted workflow enhancements such as automated needle detection for intervention procedures, and innovative camera-based patient positioning workflows. They improve clinical accuracy and efficiency while ensuring patient comfort and safety.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed for producing high-quality cross-sectional images and spectroscopic images of the head, body, and extremities. It helps clinicians diagnose by providing detailed anatomical and functional images that can be interpreted by trained physicians. This device is designed to meet industry imaging standards and includes advanced components such as RF coils and gradient amplifiers to ensure high image quality.

BoneMRI is an AI-powered software that enhances MRI images to better visualize bone structures in the pelvic and spine regions. It improves the contrast of bone relative to soft tissue to assist radiologists and orthopedic surgeons in assessing bone morphology and tissue radiodensity without replacing CT imaging. It supports clinical use in patients aged 12 and older and operates via hospital networks, ensuring data security.

NemoScan is a dental implant and surgery planning software that reads CT or CBCT medical images to simulate and evaluate patient anatomy, plan implant placement, and design surgical guides. It helps dental professionals prepare customized surgical plans and export guides for manufacturing, improving precision and treatment outcomes.

Rapid (6.0) by iSchemaView, Inc. is a medical imaging software designed to process and analyze dynamic and functional imaging data from CT and MRI scans. It aids clinicians by providing advanced visualization, quantification, and analysis tools to help select acute stroke patients for treatment, enhancing diagnostic confidence and workflow efficiency.

The Butterfly iQ3 Ultrasound System is a portable, hand-held ultrasound device used by trained healthcare professionals to capture diagnostic ultrasound images and measurements across multiple clinical areas such as cardiac, abdominal, lung, musculoskeletal, fetal/obstetric, and more. It offers various imaging modes and supports professional use in diverse healthcare environments, helping clinicians visualize anatomical structures and fluids for adult and pediatric patients.

Syngo Carbon Clinicals is a software package that provides advanced visualization tools to help healthcare professionals prepare, measure, and analyze medical images from modalities such as CT and MRI. It supports manipulation and communication of clinical data, enabling qualitative and quantitative assessment to assist in diagnosis and treatment planning.

MAGNETOM Avanto fit and MAGNETOM Skyra fit are advanced MRI systems designed by Siemens that provide high-quality magnetic resonance imaging. These devices produce detailed cross-sectional images as well as spectroscopic data of the head, body, and extremities, helping physicians diagnose a variety of conditions and support imaging during interventional procedures with MR compatible devices.

SwiftMR is a software tool that automatically enhances MRI images by reducing noise and increasing sharpness using deep learning techniques. It integrates with medical imaging systems (PACS or MRI machines) to improve image quality, aiding radiologists and clinicians in better interpreting MRI scans.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound device that wirelessly connects to iOS or Android devices to provide real-time, high-resolution diagnostic ultrasound images across many clinical applications such as cardiac, abdominal, pediatric, and musculoskeletal imaging. It helps healthcare professionals by offering dual-array transducer functionality in a single device, enhancing convenience and efficiency during ultrasound exams.