# K130058: Endoscopic Ultrasound Center EU-Y0008

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Feb 22, 2013 after 44 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: 13 generations back to K935595 (1995). 115 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 120 devices in its family (counting itself) have 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 24.
- K093466: HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision Preirus, Hitachi Medical Systems America, Inc. (2010) Summary page 24.

## Most influential descendants
- K203128: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2 Premier Plus (2020), 1 descendant of its own
- K171207: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (2018), 1 descendant of its own
- K243502: Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3  (Olympus EU-ME3) (2025), 0 descendants of its own
- K214089: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (2022), 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.

Source page: https://510kreport.com/device/K130058
Methodology: https://510kreport.com/methodology