FDA Radiology AI Devices

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.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.

The SIGNA Prime Elite is a whole body magnetic resonance imaging (MRI) scanner that offers high resolution and short scan times. It produces detailed images across multiple planes of the entire body, including the head, spine, heart, and musculoskeletal regions, assisting physicians in diagnostic interpretation to support detection and evaluation of various medical conditions.

SureWave Elastography is an accessory device for Siemens MRI systems that generates shear wave vibrations during MRI scans to create images showing tissue stiffness. This advanced imaging helps physicians diagnose tissue abnormalities by providing detailed stiffness maps alongside traditional MRI images.

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 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 NIDO Baby Magnetic Resonance Imaging System is a specialized MRI device designed for imaging the brains of newborns and infants. It provides high-quality axial, sagittal, coronal, and oblique images of the internal structure of neonatal or infant heads, aiding doctors in diagnosis without using ionizing radiation. This system features a 0.35 Tesla permanent magnet with an open design optimized for safe and comfortable neonatal imaging.

SyMRI is a software tool that processes MRI data to generate detailed maps of brain tissue properties and volumetric measurements. It enables visualization of multiple image contrasts from a single MRI scan and allows clinicians to adjust image contrasts after acquisition. This helps in better diagnosis and understanding of brain health by providing comprehensive and quantifiable tissue information.