FDA Radiology AI Devices

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.

True Enhance DL is a deep learning-based software from GE Healthcare Japan Corporation that enhances contrast in standard 120 kVp CT images of the body, making details clearer without requiring changes to acquisition parameters. It is intended to assist clinicians by providing improved image contrast to aid diagnosis and is suitable for patients of all ages.

The uMR 680 is a 1.5T superconducting magnetic resonance imaging device that produces detailed anatomical and functional images to assist physicians in diagnosis. It includes components such as magnets, RF coils, and software for imaging the head, body, and extremities, helping clinicians with diagnostic imaging using MRI technology.

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.