EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced diagnostic ultrasound devices that use AI-powered AutoMeasure V3 software to provide semi-automated 2D, Doppler, and M-mode measurements for adult echocardiography. These systems help healthcare professionals efficiently perform and analyze cardiac ultrasound exams, improving measurement accuracy and workflow in clinical environments such as hospitals and clinics.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body, including multiple indications such as abdominal, cardiac adult, fetal, pediatric, cerebral vascular, musculoskeletal, and others.
Technology
Semi-automated software (AutoMeasure V3) using AI and machine learning algorithms to provide 2D, Doppler, and M-mode measurements in adult cardiac transthoracic echocardiography with ECG acquisitions, integrated with Philips EchoNavigator for guidance in cardiovascular procedures.
Performance
Performance validation study with 7,127 cardiac transthoracic echocardiography clips from 3,964 subjects across diverse demographics and clinical settings demonstrated AutoMeasure V3 achieves clinically acceptable agreement with standard of care measurements, supporting safety and effectiveness of the semi-automated AI measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/10/2024
1 month - 2
FDA Approval
2/6/2025
Other devices from Philips Ultrasound LLC
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