# K243502: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3) - Pathway: 510(k) (Traditional) - Applicant: Olympus Medical Systems Corporation - Decided: Jan 17, 2025 after 66 days - Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic) - Device class: 2 - Regulation: 21 CFR 892.1550 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 15 generations back to K935595 (1995). 127 ancestors in all. No later device cites it as a predicate yet. 1 of 128 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K203128: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2 Premier Plus, Olympus Medical Systems Corp. (2020) Summary page 6. ## Indications for 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). B mode, PWD (Pulsed Wave Doppler) mode, Color Doppler (including Power Doppler) mode, combinations of each mode of operation (B mode, PWD mode, Color Doppler mode) and Other (Harmonic Imaging, Elastography and Shear Wave Speed Measurement [Shear Wave Quantification]). Appropriately trained healthcare professionals. Hospital or Patient care facility. Source page: https://510kreport.com/device/K243502 Methodology: https://510kreport.com/methodology