FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

Vista OS, Vista AI Scan, and RTHawk are AI-based systems designed to work with MRI imaging. These systems help clinicians acquire and process MRI scans more efficiently, potentially improving imaging quality and reducing scan time to assist diagnosis and patient care.

FDA #
K251029
Product Code
LNH

The InVision™ 3T Recharge Operating Suite is a system designed for magnetic resonance imaging (MRI). It helps clinicians by providing high-quality images of the body’s internal structures, aiding in diagnosis and treatment planning. This advanced MRI system supports detailed and clear imaging, improving patient care in radiology.

FDA #
K252239
Product Code
LNH

The uMR Jupiter is an MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It produces detailed images of the body's internal structures using nuclear magnetic resonance, aiding clinicians in diagnosis and treatment planning.

FDA #
K250246
Product Code
LNH

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.

FDA #
K250901
Product Code
LNH

The uMR Ultra is an MRI system developed by Shanghai United Imaging Healthcare. It uses nuclear magnetic resonance imaging technology to create detailed images of the body's internal structures, helping clinicians diagnose and monitor various medical conditions.

FDA #
K243547
Product Code
LNH

The uMR 680 is a nuclear magnetic resonance imaging system developed by Shanghai United Imaging Healthcare. It provides detailed internal body images useful for diagnosis and treatment planning, helping clinicians visualize patient anatomy non-invasively.

FDA #
K243397
Product Code
LNH

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.

FDA #
K251808
Product Code
LNH

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.

FDA #
K250443
Product Code
LNH

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.

FDA #
K250436
Product Code
LNH

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.

FDA #
K243667
Product Code
LNH
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