FDA Radiology AI Devices

Sonic DL is a software feature for GE HealthCare MR systems that uses deep learning algorithms to reconstruct MR images from highly under-sampled data, enabling faster image acquisition and maintaining diagnostic quality. It supports multiple MR field strengths and is used across various anatomies, including cardiac, brain, spine, musculoskeletal, abdomen, pelvis, and breast imaging, helping clinicians obtain high-quality MR images more quickly.

The Ingenia MR system family by Philips includes 1.5T and 3.0T MRI scanners that produce detailed cross-sectional and spectroscopic images of the body. It helps physicians diagnose and plan treatments by providing high-quality images of the head, body, and extremities. The system features an AI-based image reconstruction software called SmartSpeed Precise, which improves image sharpness and signal-to-noise ratio while reducing artifacts, enhancing image quality without changing intended use or safety.

The Swoop® Portable MR Imaging® System (V2) by Hyperfine, Inc. is a portable, ultra-low field MRI device designed to image the internal structure of the head. It is intended for use in clinical settings where full diagnostic MRI exams may not be practical, providing clinicians with images that aid in diagnosis. The system features advanced image reconstruction using deep learning to optimize image quality, enhancing visualization while being convenient and fast to deploy at the point of care.

The Swoop® Portable MR Imaging® System is a portable, ultra-low field MRI device that produces images of the internal structure of the head. It incorporates a deep learning-based image reconstruction algorithm to enhance image quality, helping healthcare providers diagnose patients at the point of care, especially where full diagnostic exams are not practical.

SCENARIA View Phase 5.0 is a multi-slice CT system that acquires axial volumes of the whole body in various scan modes. It includes AI-based features such as AutoPose that automatically recognizes and sets scan ranges for body parts, improving workflow and scan accuracy. The system supports high-quality imaging with motion correction and provides enhanced post-processing capabilities to assist clinicians in diagnosis and interventional guidance.

MapRT is a software system used by radiotherapy professionals during the CT simulation and treatment planning stages to model 3D patient and equipment geometry. It helps to avoid collisions between the treatment machine, patient, and accessories, and facilitates dose optimization by providing a clearance map for various gantry and couch angles. This improves treatment safety and planning efficiency.

The Spectral CT system by Philips is an advanced CT scanner that acquires dual-energy X-ray data to provide detailed cross-sectional images of the body. This technology enables the analysis of different materials' chemical composition and improves visualization of anatomical and pathological structures, aiding clinicians in diagnostic imaging and treatment planning across multiple clinical areas including radiology, cardiology, and oncology.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis and uCT ATLAS with uWS-CT-Dual Energy Analysis are advanced CT imaging systems that produce cross-sectional whole-body images using X-rays. They incorporate AI-based technologies to enhance image reconstruction, reduce artifacts, and improve diagnostic quality, particularly for cardiac imaging and lung cancer screening. The systems support low dose CT for early lung nodule detection and use dual energy imaging for detailed tissue characterization.

The Dental Cone Beam Computed Tomography System by Yofo Medical Technology Co., Ltd. is designed for dental and maxillofacial imaging using cone beam CT technology. It produces detailed 3D images of patients' oral and maxillofacial regions to assist clinicians in diagnosis and treatment planning, improving patient care in dental and maxillofacial medicine.

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.