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.

Showing 1566 FDA devices.

Brain WMH by Quantib BV is an automated software tool designed to analyze brain MRI images for white matter hyperintensities (WMH). It helps clinicians identify and quantify these lesions, improving diagnosis and monitoring of neurological conditions.

FDA #
K251527
Product Code
QIH

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 Digital X-Ray DentiMax Pro Imaging System is an advanced digital extraoral X-ray imaging device used primarily in dental radiology. It helps dentists capture high-quality images of the oral and maxillofacial region to assist in diagnosis and treatment planning.

FDA #
K251206
Product Code
MUH

The uWS-Angio Pro is an image processing system developed by Shanghai United Imaging Healthcare Co., Ltd. It is used in radiology to assist clinicians by processing medical images, potentially improving the visualization and analysis of angiographic studies.

FDA #
K250045
Product Code
LLZ

SwiftSight-Brain is a software designed to assist clinicians by automatically processing radiological images of the brain. It helps improve diagnostic efficiency by analyzing brain imaging data to support radiologists in identifying abnormalities.

FDA #
K251483
Product Code
QIH

Rapid Aortic Measurements is an AI-powered software product designed to automatically process radiological images to assist clinicians in measuring aortic structures quickly and accurately.

FDA #
K251987
Product Code
QIH

Videa Dental AI is a medical imaging AI product designed to analyze radiology images related to dental applications. It helps clinicians by providing automated assessment of dental images, supporting decision-making and improving diagnostic efficiency.

FDA #
K251002
Product Code
MYN

The uDR Aurora CX is a stationary X-Ray system designed for radiology applications. It helps clinicians obtain high-quality X-Ray images which can be used for diagnostic purposes, potentially supporting AI tools in image analysis and patient care.

FDA #
K251167
Product Code
KPR

The ULTRASONIC PROBE UM-3R and UM-G20-29R are diagnostic ultrasonic transducers used to produce ultrasound images for medical evaluation. These probes help clinicians visualize internal organs and tissues noninvasively to aid in diagnosis and treatment planning.

FDA #
K250883
Product Code
ITX

Axial3D Insight is a software that automatically processes radiological images to help clinicians analyze complex anatomical structures. It aims to enhance medical imaging interpretation and assist in treatment planning.

FDA #
K250369
Product Code
QIH
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