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 1617 FDA devices.

Archy Dental Imaging is a radiological image processing system designed for dental applications. It assists clinicians by enhancing and analyzing dental radiographs to improve diagnostic accuracy and patient care.

FDA #
K251880
Product Code
LLZ

MAGNETOM Free.Max and MAGNETOM Free.Star are MRI systems provided by Siemens Shenzhen Magnetic Resonance that help clinicians capture detailed images of the body's internal structures. These advanced MRI systems support medical diagnosis and treatment planning by providing high-quality nuclear magnetic resonance images.

FDA #
K251822
Product Code
LNH

syngo.MR Applications (VB80) by Siemens Healthineers is an advanced image processing system designed for radiology. It helps clinicians by processing and enhancing MRI images, facilitating better diagnosis and analysis of medical conditions using magnetic resonance imaging.

FDA #
K253495
Product Code
LLZ

The ACUSON Maple Diagnostic Ultrasound System is an imaging device used in radiology that employs pulsed Doppler ultrasonic technology to create diagnostic images. It assists clinicians in examining internal structures of patients by providing real-time ultrasound images, aiding diagnosis and patient care.

FDA #
K253487
Product Code
IYN

DTX Studio Assist is an AI-powered medical image analysis tool designed to help clinicians by analyzing radiology images. It assists in interpreting medical images to support diagnostic decisions.

FDA #
K252086
Product Code
MYN

AutoDensity is an automated image processing software used in radiology to assist clinicians by analyzing medical images efficiently and accurately. It supports healthcare providers in interpreting images, potentially improving diagnostic speed and accuracy.

FDA #
K251078
Product Code
QIH

Second Opinion® Panoramic by Pearl, Inc. is a medical imaging AI product designed to analyze panoramic radiology images. It assists clinicians by enhancing image interpretation accuracy and efficiency in radiology.

FDA #
K250525
Product Code
MYN

The ACUSON Juniper Diagnostic Ultrasound System is a medical imaging device that uses ultrasound technology to create images of the body's internal structures, helping clinicians in diagnosis and patient care. It employs pulsed Doppler ultrasound for detailed imaging and assessment.

FDA #
K253457
Product Code
IYN

This product is a dental computed tomography (CT) X-ray system that provides detailed 3D images of dental structures. It helps dentists and clinicians by offering precise imaging that supports diagnosis and treatment planning in dental care.

FDA #
K251842
Product Code
OAS

PeekMed web is an automated image processing software designed for radiology. It helps clinicians by analyzing radiological images using AI algorithms, potentially improving diagnostic accuracy and workflow efficiency.

FDA #
K252452
Product Code
QIH
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