EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound LLCThe EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC provide advanced ultrasound imaging and fluid flow analysis for various body regions, including cardiac adult imaging. These systems incorporate AI-driven software features such as Segmental Wall Motion Version 2 (SWM v2) and Auto EF with contrast, which assist clinicians in automating the evaluation of left ventricular function and ejection fraction using transthoracic echocardiography. This helps healthcare providers make more accurate and efficient cardiac assessments during diagnostic imaging.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body, including applications for adult cardiac imaging with AI-based software to assist in cardiovascular assessment.
Technology
The device incorporates software applications SWM Version 2 and Auto EF with contrast, which use machine learning algorithms on ultrasound images from apical views of the heart to semi-automatically evaluate left ventricular segmental wall motion and calculate left ventricular ejection fraction with contrast agents. These software features integrate with existing ultrasound hardware without modifications.
Performance
Performance testing included retrospective clinical data analyses comparing AI-generated cardiac segmental wall motion scores and ejection fraction measurements against expert cardiologist visual estimates and manual assessments using Simpson's method, demonstrating sensitivity, specificity, and correlation metrics meeting predefined acceptance criteria, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/11/2025
28 days - 2
FDA Approval
5/9/2025
Other devices from Philips Ultrasound LLC
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.