EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
Olympus Medical Systems CorporationThe EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 is a real-time endoscopic ultrasound imaging system designed to be used with Olympus ultrasound endoscopes and probes. It captures ultrasound images within various internal organs such as the gastrointestinal tract, biliary and pancreatic ducts, and others. The system supports various ultrasound modes including B mode, Doppler modes, harmonic imaging, elastography, and shear wave quantification to provide comprehensive diagnostic information, helping clinicians in diagnosis and treatment planning.
Intended Use
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe real-time ultrasound images and is indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, intraluminal ultrasound for airways, tracheobronchial tree, trans-rectal, trans-urethral, and trans-esophageal (non-cardiac).
Technology
The system combines compatible ultrasound video scopes or probes with a keyboard interface to generate and display real-time endoscopic and ultrasound images. It uses ultrasound transducers that emit ultrasound waves powered by driving voltage, facilitating multiple modes including B mode, Pulsed Wave Doppler, Color Doppler, Harmonic Imaging, Elastography, and Shear Wave Speed Measurement. The system also allows image and movie storage, retrieval, printing, and external recording.
Performance
The device underwent extensive non-clinical testing including bench tests for acoustic output, measurement accuracy for strain ratio, distance, circumference, area, velocity, elastography strain visualization, and contrast harmonic echo. It also completed human factors evaluation, cleaning/disinfection validation, software and cybersecurity testing, and electrical safety and EMC testing. The nonclinical tests demonstrated that the device is as safe, effective, and performs as well or better than the predicate device. No clinical data were collected.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/12/2024
2 months - 2
FDA Approval
1/17/2025
Other devices from Olympus Medical Systems Corporation
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.