EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe EPIQ Series Diagnostic Ultrasound System by Philips Ultrasound LLC is a diagnostic ultrasound imaging device used to visualize and analyze fluid flow in the human body. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and ophthalmic imaging, enhancing clinicians' ability to diagnose and guide treatment with high-resolution imaging and fluid flow analysis.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body across a wide range of clinical applications including abdomen, cardiac (adult and fetal), cerebral vascular, cephalic, fetal/obstetric, gynecological, intraoperative vascular and cardiac, musculoskeletal, ophthalmic, small organs, pediatric, lung, and more.
Technology
The system includes a newly introduced mL26-8 linear array transducer designed for high-resolution superficial imaging (6-13.33 MHz) in musculoskeletal, ophthalmic, peripheral vessels, and small organs. It supports integration with Philips EchoNavigator for combined live X-ray and live echo guidance during cardiovascular interventions. The device complies with international safety and performance standards, and includes software that meets medical device software lifecycle requirements.
Performance
Nonclinical performance testing conducted included compliance with multiple international standards for safety, electromagnetic compatibility, usability, ultrasonic field characterization, and biological evaluation. The device met all predetermined acceptance criteria through design control activities and did not require clinical data because substantial equivalence was demonstrated by design features, indications for use, and testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/26/2023
16 days - 2
FDA Approval
5/12/2023
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