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 1700 FDA devices.

The uCT 780 with uWS-CT-Dual Energy Analysis is a computed tomography (CT) system designed to perform advanced imaging using dual energy analysis techniques. This helps clinicians obtain detailed images of the body's internal structures, improving diagnosis and patient care.

FDA #
K253173
Product Code
JAK

Aplio beyond and Aplio me Software V2.0 is a diagnostic ultrasound system designed to assist clinicians by providing high-quality pulsed Doppler ultrasound images. It helps in visualizing blood flow and organs, aiding in diagnosis and patient care.

FDA #
K253597
Product Code
IYN

The DRX-Evolution Plus and DRX-Compass Mobile are X-ray systems equipped with high-definition detectors designed to capture detailed radiographic images for clinical use, aiding clinicians in diagnosis and patient care.

FDA #
K250954
Product Code
KPR

Azurion R3.1 is an advanced interventional fluoroscopic X-ray system designed to assist clinicians during image-guided procedures by providing high-quality real-time X-ray imaging, improving precision and patient outcomes.

FDA #
K254186
Product Code
OWB

Imagine® Enterprise Suite by Softlink International Private Limited is an automated radiological image processing software designed to assist clinicians by analyzing radiology images to improve diagnostic accuracy and efficiency.

FDA #
K252634
Product Code
QIH

qXR-Detect is a medical imaging analysis tool designed to assist radiologists by automatically analyzing chest X-ray images to detect and highlight potential abnormalities, helping in faster and more accurate diagnosis.

FDA #
K251934
Product Code
MYN

Diagnocat is an AI-powered software designed to analyze medical images, assisting clinicians by providing automated insights from radiology scans. It helps improve diagnostic accuracy and workflow efficiency.

FDA #
K252934
Product Code
MYN

BIOGRAPH One by Siemens Healthineers AG is an advanced tomographic imaging device that integrates emission computed tomography and nuclear magnetic resonance technologies. It helps clinicians by providing detailed images that combine functional and anatomical information, facilitating accurate diagnosis and patient management.

FDA #
K253023
Product Code
OUO

The Orthoscan TAU MVP Mini C-Arm System is a mobile fluoroscopic X-ray device that provides real-time imaging to assist clinicians during medical procedures, enabling better visualization of anatomy for accurate treatment and improved patient care.

FDA #
K252579
Product Code
OXO

The VERITON CT 300 and 400 Series Digital SPECT/CT Systems combine CT and SPECT imaging to provide detailed anatomical and functional images. This helps clinicians better diagnose and manage diseases by combining structural and metabolic information in one device. It supports improved patient care through enhanced imaging capabilities.

FDA #
K254001
Product Code
KPS
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