FDA Radiology AI Devices

SubtleHD (1.x) is an AI-based image processing software designed to enhance MRI images from any body part. It improves image quality by reducing noise and increasing sharpness, helping radiologists obtain clearer images without changing the original scan process. This facilitates improved diagnostic confidence and visualization of anatomical structures.

The DigitMI 930 is a PET/CT imaging system that combines positron emission tomography and computed tomography to produce detailed images of metabolic and physiological functions in the body. It helps clinicians detect, localize, evaluate, diagnose, and monitor a wide range of conditions including cancer, cardiovascular disease, and neurological disorders by providing precise anatomical and functional imaging.

Prenuvo Body Composition is an MRI-based system that analyzes the body's composition. It helps clinicians assess various tissues in the body non-invasively, supporting diagnosis and patient management in radiology.

The Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.

The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system designed to produce detailed cross-sectional images of the head or body. It incorporates AI-based deep learning technology, called the Precise IQ Engine (PIQE), which enhances image resolution, reduces artifacts, and maintains or improves image quality. This helps clinicians obtain clearer and more precise images for diagnosis without additional scan time or parameters adjustment.

The uCT 780 is a computed tomography (CT) system designed to produce cross-sectional images of the body including head, neck, chest, cardiac and vascular regions. It offers advanced AI-driven image reconstruction to improve image quality and reduce radiation dose, supporting lung cancer screening and various diagnostic tasks. This helps clinicians obtain clearer images for diagnosis while lowering radiation exposure for patients.

The Digital Radiography X-ray System by Shenzhen SONTU Medical Imaging Equipment Co. is a modular digital X-ray system used in hospitals and clinics. It produces high-quality digital images of the whole body, including skull, chest, abdomen, and extremities, helping clinicians diagnose a wide range of conditions. The system supports various patient positions and utilizes digital detectors to convert X-rays into image signals quickly and accurately, enhancing clinical workflow and patient care.

The Adora DRFi is a ceiling suspended, universal X-ray system designed for diagnostic radiography and fluoroscopy. It supports a wide range of whole-body X-ray examinations in both adult and pediatric patients and features a flat panel detector for direct radiography and radioscopy. The system improves ergonomics and workflow while enabling imaging in various patient positions including supine, standing, sitting, wheelchair, or stretcher. It is intended for use by trained healthcare professionals and is not for mammography.

Aquilion ONE (TSX-308A/3) V1.5 is a whole-body multi-slice helical CT scanner capable of imaging entire organs in a single rotation. It uses AI-powered deep learning reconstruction and noise reduction algorithms to enhance image quality, reduce radiation dose, and minimize artifacts. This helps clinicians obtain clearer diagnostic images for various body regions including the head, chest, abdomen, pelvis, cardiac, extremities, and lungs, supporting better patient diagnosis and treatment planning.