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.

GBrain MRI by Galileo CDS, Inc is an AI-powered software designed to process MRI images automatically, helping radiologists interpret brain scans more efficiently.

FDA #
K252362
Product Code
QIH

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

GyriCalc (Version 1.0.0) is a radiological image processing system designed to assist clinicians by analyzing brain images. It helps in quantifying gyri patterns in the brain, which can aid in neurological assessments and diagnosis.

FDA #
K250686
Product Code
LLZ

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 e2Coil™ Imaging System is a specialized magnetic resonance coil designed to be used with Siemens MAGNETOM 3.0T MRI systems that have the Tim 4G connector. This coil improves the MRI imaging capabilities by enhancing signal reception, thereby helping clinicians obtain clearer and more detailed images for diagnosis and patient care.

FDA #
K243428
Product Code
MOS

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
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