EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Medical SystemsThe Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems are advanced ultrasound imaging devices used to capture diagnostic ultrasound images and analyze fluid flow in various parts of the human body. These systems include an AI-powered Auto Measure feature that semi-automates 2D and Doppler measurements during echocardiography, helping clinicians perform more efficient and standardized assessments with editable, semi-automated results.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body in multiple anatomical regions including abdominal, cardiac, cerebral vascular, musculoskeletal, and others.
Technology
The system includes an AI/ML-enabled Auto Measure software feature providing semi-automated, editable 2D and Doppler measurements during transthoracic echocardiography exams. The software allows the user to accept, edit, or reject the measurements, enhancing efficiency and consistency without altering core indications or device principles.
Performance
The Auto Measure feature was tested via Philips' internal design controls including risk management, design reviews, and software verification and validation. Performance validation studies demonstrated the AI-based feature meets defined requirements and is substantially equivalent to manual measurements on predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/24/2021
3 months - 2
FDA Approval
9/8/2021
Other devices from Philips Medical Systems
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.