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 239 FDA devices matching your filters.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that help clinicians visualize and assess various body regions using pulsed Doppler technology. These systems support medical diagnosis by providing high-quality ultrasound images and measurements, facilitating patient care in many clinical settings.

FDA #
K251651
Product Code
IYN

The EVIS EUS Ultrasound Gastrointestinal Videoscope by Olympus is an advanced endoscopic ultrasound device that allows physicians to visualize the gastrointestinal tract using ultrasound technology. This helps clinicians diagnose and assess gastrointestinal conditions more accurately by combining endoscopy with ultrasound imaging.

The Shear Wave Quantificational Ultrasound Diagnostic System is an advanced ultrasound machine that uses shear wave technology to provide quantitative assessment of tissue stiffness. This helps clinicians evaluate various conditions by producing detailed images and measurements, improving diagnosis and treatment planning.

FDA #
K250026
Product Code
IYN

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

The ViewMate Ultrasound System by Shenzhen Mindray is a pulsed Doppler ultrasound imaging system. It provides clinicians with ultrasound imaging capabilities to assist in diagnostic examinations, helping to visualize blood flow and other physiological data non-invasively.

FDA #
K251820
Product Code
IYN

The ViewMate™ Multi Ultrasound System is an ultrasound imaging device that helps clinicians by providing high-quality pulsed Doppler ultrasonic images. It supports the diagnosis and assessment of various medical conditions by visualizing blood flow and tissue structures in real time.

FDA #
K251250
Product Code
IYN

The Sonosite LX and Sonosite PX Ultrasound Systems are medical devices that use pulsed Doppler ultrasound technology to create images of the inside of the body. These systems help clinicians visualize and assess various tissues and organs in real time, supporting diagnosis and treatment decisions.

FDA #
K251106
Product Code
IYN

The ACUSON Sequoia and ACUSON Origin Diagnostic Ultrasound Systems by Siemens are advanced ultrasound imaging devices used by clinicians to visualize internal structures of the body in real-time. They help in diagnosing a variety of conditions by providing high-quality ultrasonic images, aiding patient care through non-invasive and versatile imaging.

FDA #
K251481
Product Code
IYN

The Deepsight NeedleVue LC1 Ultrasound System is an imaging device that uses pulsed echo ultrasound technology. It helps clinicians visualize internal anatomy in real-time to guide procedures such as needle placements more accurately and safely.

FDA #
K250381
Product Code
IYO
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