# K203128: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2 Premier Plus - Pathway: 510(k) (Special) - Applicant: Olympus Medical Systems Corp. - Decided: Nov 9, 2020 after 21 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: 14 generations back to K935595 (1995). 126 ancestors in all. 1 later device descends from it; 1 cites it directly. 1 of 128 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K121564: Endoscopic Ultrasound Center EU-Y0006, Olympus Medical Systems Corp. (2012) Summary page 5. - K130058: Endoscopic Ultrasound Center EU-Y0008, Olympus Medical Systems Corp. (2013) Summary page 5. - K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System, Olympus Medical Systems Corporation (2007) Summary page 5. ## Most influential descendants - K243502: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3) (2025), 0 descendants of its own ## Indications for use This ultrasound center is intended to be used with Olympus ultrasound endoscopes, Olympus ultrasound probes or Olympus esophageal ultrasound probes to observe and to store real-time ultrasound images and indicated for use within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree, and urinary tract. B, PWD (Pulsed Wave Doppler), Color Doppler (including Power Doppler), Combined (combination of each operating mode) and other (3-D Imaging and Harmonic Imaging*). *Only for the EU-ME2 PREMIER PLUS. Appropriately-trained healthcare professional. Hospital. Source page: https://510kreport.com/device/K203128 Methodology: https://510kreport.com/methodology