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 233 FDA devices matching your filters.

AIAS Cephalon by metamorphosis GmbH is an AI software tool designed to assist in processing radiological images automatically, helping clinicians analyze medical images more efficiently and accurately.

FDA #
K252214
Product Code
QIH

Ligence Heart is an AI-driven software designed to automatically process radiological images for cardiac assessment. It helps clinicians by providing automated analysis of heart images, potentially improving diagnostic efficiency and accuracy.

FDA #
K252105
Product Code
QIH

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

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

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

AngioWaveNet is software designed to automatically process radiological images, helping clinicians analyze images more efficiently and accurately by leveraging artificial intelligence.

FDA #
K244002
Product Code
QIH

Segmentron Viewer is an automated software tool designed for processing radiological images to assist clinicians by improving image analysis and interpretation for medical purposes.

FDA #
K251072
Product Code
QIH

Careverse CoronaryDoc is an automated software designed for processing radiological images, helping clinicians analyze coronary images more efficiently and accurately.

FDA #
K251656
Product Code
QIH

Tempus Pixel is a software product that uses AI to automate the processing of radiological images, helping clinicians analyze medical scans more efficiently and accurately.

FDA #
K252539
Product Code
QIH
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