# K190449: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Aug 30, 2019 after 186 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: 9 generations back to K931154 (1993). 33 ancestors in all.
5 later devices descend from it; 3 cite it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190, Olympus Medical Systems Corp. (2012) Summary page 6.
- K102059: Autoclavable Camer Head Model Otv-Y0017, Olympus Medical Systems Corporation (2010) Summary page 6.

## 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
- K261260: HD Camera Head OLYMPUS CH-S200-08-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
- K200542: Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head (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. The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

Source page: https://510kreport.com/device/K190449
Methodology: https://510kreport.com/methodology