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.
Tip: combine filters with the search box to narrow down devices.

Showing 93 FDA devices matching your filters.

The uMR 680 is a magnetic resonance imaging (MRI) system produced by Shanghai United Imaging Healthcare Co., Ltd. It helps clinicians visualize detailed internal body structures to diagnose and monitor various medical conditions, enhancing patient care through advanced imaging capabilities.

FDA #
K252371
Product Code
LNH

The ECHELON Synergy is an MRI system developed by Fujifilm Corporation that helps clinicians obtain detailed images of internal body structures using nuclear magnetic resonance. This enables doctors to diagnose and monitor various medical conditions with precision.

FDA #
K251386
Product Code
LNH

SIGNA™ Sprint is an MRI imaging system from GE Medical Systems that helps clinicians capture detailed images of the body using nuclear magnetic resonance. It supports diagnostic imaging to detect and evaluate a variety of medical conditions, aiding doctors in diagnosis and treatment planning.

FDA #
K251399
Product Code
LNH

MuscleView 2.0 is an MRI imaging system that aids clinicians in visualizing and analyzing muscle tissue. It helps radiologists and healthcare providers obtain detailed images of muscle anatomy for diagnosis and treatment planning.

FDA #
K251682
Product Code
LNH

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
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