# K201200: Visera Elite II Video System Center

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jul 22, 2020 after 79 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: 11 generations back to K931154 (1993). 41 ancestors in all.
4 later devices descend from it; 2 cite it directly.
3 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193026: Visera Elite II Video System Center, Visera Elite II Endoeye 3D, Olympus Medical Systems Corp. (2020) Summary page 5.

## Most influential descendants
- K242067: Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source Olympus CLL-S700; 4K Camera Head Olympus CH-S700-XZ-EA (2025), 2 descendants of its own
- K262079: 4K Camera Head OLYMPUS CH-S700-08-LB (2026), 0 descendants of its own
- K251336: VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (2025), 0 descendants of its own
- K202646: Visera Elite II Video System Center (2020), 0 descendants of its own

## Indications for use
This video system center 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/K201200
Methodology: https://510kreport.com/methodology