# K232518: EndoSound Vision System; EVS

- Pathway: 510(k) (Traditional)
- Applicant: Endosound, Inc.
- Decided: Dec 27, 2023 after 131 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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). 98 ancestors in all.
No later device cites it as a predicate yet.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093395: Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound Gastrovideoscope, Olympus Medical Systems Corporation (2010) Summary page 4.
- K134016: Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner, Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (2014) Summary page 4.
- K200090: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type), Pentax of America, Inc. (2020) Summary page 7.

## Indications for use
The EndoSound Vision System (EVS), when affixed to an endoscope, is intended to provide ultrasonic visualization of, and ultrasound guided therapeutic access to the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The EVS, mounted on an endoscope, is introduced orally when indications consistent with the requirement for a GI procedure are met. The EVS is a prescription only device to be used by a qualified physician. The clinical environments where the system can be used include clinics, hospitals, and ambulatory surgery centers.

Source page: https://510kreport.com/device/K232518
Methodology: https://510kreport.com/methodology