EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe EPIQ Series Diagnostic Ultrasound System by Philips is an advanced ultrasound imaging device that uses AI-powered software to aid clinicians in semi-automated quantification of heart valve function, specifically assessing the tricuspid valve and mitral valve regurgitation. This helps improve accuracy and efficiency in diagnosing cardiac conditions by providing detailed measurements and flow analysis from 3D ultrasound images.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body with clinical indications including cardiac and other organs.
Technology
The system includes software applications 3D Auto TV and 3D Auto CFQ which provide semi-automated quantification of tricuspid valve anatomy and mitral regurgitation flow volume and peak flow rate, using 3D ultrasound image segmentation and a fluid dynamics model adapted to color flow images.
Performance
Performance validation studies demonstrated high agreement of automated measurements with ground truths including manual measurement software and cardiac magnetic resonance imaging (CMR) as a gold standard, meeting acceptance criteria and supporting clinically reasonable performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/10/2024
6 months - 2
FDA Approval
10/7/2024
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.