# K202646: Visera Elite II Video System Center

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corp.
- Decided: Oct 29, 2020 after 48 days
- Product code: FET (Endoscopic Video Imaging System/Component, 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: 12 generations back to K931154 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201200: Visera Elite II Video System Center, Olympus Medical Systems Corp. (2020) Summary page 5.

## Indications for use
The Visera Elite II Video System Center (OLYMPUS OTV-S300) is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

Source page: https://510kreport.com/device/K202646
Methodology: https://510kreport.com/methodology