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.

The B-Scan device by ACCUTOME, INC. is an ultrasound imaging system that uses pulsed echo technology to capture images inside the body. It assists clinicians by providing detailed images useful for diagnosis and treatment planning in radiology.

FDA #
K243227
Product Code
IYO

This product consists of ultrasonic probes used in diagnostic imaging. These probes emit and receive ultrasound waves to create images of the body's internal structures, helping clinicians visualize and assess patients non-invasively.

FDA #
K250762
Product Code
ITX

The Sonosite LX Ultrasound System by FUJIFILM Sonosite is an advanced ultrasound imaging device used in medical settings. It assists clinicians by providing high-quality ultrasound and Doppler images, facilitating diagnosis and patient care in radiology.

FDA #
K251830
Product Code
IYN

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

FDA #
K251169
Product Code
IYN

The Mendaera Guidance System is an ultrasonic diagnostic transducer designed to assist clinicians in medical imaging procedures by providing real-time ultrasound images. It helps healthcare providers visualize internal structures, aiding in diagnosis and treatment guidance.

FDA #
K250524
Product Code
ITX

The Digital Color Doppler Ultrasound System (P60 Series) by Sonoscape Medical Corp. is an advanced ultrasound imaging instrument that uses multiple modes including color Doppler and AI-based features to help clinicians evaluate a wide range of body regions and conditions with high detail and accuracy. It supports AI-powered automatic recognition and measurement to aid in fetal ultrasound examinations and other diagnostic exams, improving workflow efficiency and diagnostic performance.

FDA #
K241949
Product Code

The EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 is a real-time endoscopic ultrasound imaging system designed to be used with Olympus ultrasound endoscopes and probes. It captures ultrasound images within various internal organs such as the gastrointestinal tract, biliary and pancreatic ducts, and others. The system supports various ultrasound modes including B mode, Doppler modes, harmonic imaging, elastography, and shear wave quantification to provide comprehensive diagnostic information, helping clinicians in diagnosis and treatment planning.

FDA #
K243502
Product Code

Cardiac Guidance software helps medical professionals capture standard cardiac ultrasound views by providing real-time AI-powered guidance, quality feedback, and automatic image capture during echocardiography. It supports better image acquisition for accurate cardiac assessment, assisting clinicians during ultrasound exams.

FDA #
K243065
Product Code

BioTraceIO Precision (2.0) is a medical software that assists physicians by analyzing ultrasound images captured during liver ablation procedures to visualize and predict the ablation zone. It helps clinicians assess the effectiveness of radiofrequency or microwave ablation treatments by correlating ultrasound data with contrast-enhanced CT scans obtained post-procedure, improving decision-making while providing adjunctive visual information during and after treatment.

FDA #
K243084
Product Code

The Voluson Expert Series (including models 18, 20, and 22) by GE Healthcare is a range of advanced ultrasound imaging systems designed for use by trained healthcare professionals in hospitals and clinics. They provide high-performance real-time ultrasound imaging and analysis capabilities including 2D, 3D, 4D, color Doppler, power Doppler, pulse wave Doppler, harmonic imaging, elastography, and advanced AI-assisted software for obstetric and gynecologic assessments. This helps clinicians obtain detailed diagnostic images for fetal, abdominal, cardiac, musculoskeletal, and other clinical applications, supporting accurate diagnosis and patient care.

FDA #
K242168
Product Code
Page 1 of 17162 results

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.