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 EPIQ Series Diagnostic Ultrasound System by Philips is a diagnostic ultrasound imaging device that provides detailed ultrasound images and fluid flow analysis to assist clinicians in diagnosing a wide range of medical conditions across multiple body regions. It supports advanced modes such as transesophageal cardiac imaging and works in different clinical environments including hospitals and clinics. The system integrates with Philips EchoNavigator to aid in cardiovascular interventions by providing live ultrasound and X-ray guidance, enhancing the precision of treatments.

FDA #
K233545
Product Code
IYN

The Philips Lumify Diagnostic Ultrasound System is a portable ultrasound device used by healthcare professionals to capture high-resolution ultrasound images and perform fluid flow analysis in various clinical applications including cardiac imaging. It incorporates an AI-based Auto EF Quantification feature that automatically assesses cardiac function by measuring the left ventricle’s ejection fraction, improving clinical workflows during cardiac examinations.

FDA #
K232500
Product Code
IYN
Page 1 of 12 results
1

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.