FDA Radiology AI Devices

The Vantage Fortian/Orian 1.5T from Canon Medical Systems is an MRI system enhanced with the AiCE Reconstruction Processing Unit. It uses AI technology to improve image reconstruction, assisting clinicians in obtaining high-quality magnetic resonance images for diagnosis.

This product is a family of Philips MRI systems designed to produce detailed images of the body's internal structures. These MRI machines help doctors and clinicians by providing high-quality images that assist in diagnosing a variety of medical conditions across different body regions without using ionizing radiation.

The MAGNETOM Avanto Fit, MAGNETOM Skyra Fit, MAGNETOM Sola Fit, and MAGNETOM Viato.Mobile are MRI systems designed to produce detailed diagnostic images and spectra of the head, body, and extremities. They include advanced AI-based features such as Deep Resolve Boost and Deep Resolve Sharp to enhance image quality and speed, aiding radiologists in diagnosis and treatment planning.

MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are advanced 1.5T MRI systems by Siemens that produce high-resolution images of the head, body, or extremities, using MR technology and optional local coils. Equipped with AI-powered software features such as Deep Resolve for image enhancement and AutoMate Cardiac for cardiac imaging automation, these devices help clinicians obtain detailed diagnostic images efficiently and safely, facilitating diagnosis and interventional procedures.

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.

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.

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.