EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe 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.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body for multiple body regions including abdominal, cardiac, cerebral vascular, musculoskeletal, ophthalmic, lung, breast, and others. It can be used in clinics, hospitals, and point-of-care settings, supporting diagnosis and treatment guidance.
Technology
The device includes a 2500 element phased array 3D transesophageal cardiac transducer operating at 4-11 MHz, supported on multiple EPIQ system platforms running software version 11.0 or higher. It performs pulsed Doppler and pulsed echo imaging for diagnostic purposes and can integrate with EchoNavigator for live X-ray and ultrasound image guidance in cardiovascular procedures.
Performance
The system complies with multiple international standards for medical electrical equipment, electromagnetic compatibility, ultrasound safety, and biological evaluation. Non-clinical performance testing includes system-level requirements verification, risk management, design reviews, and bench testing. Clinical data were not required due to the demonstrated substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/3/2023
27 days - 2
FDA Approval
11/30/2023
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