# K062049: Evis Exera II 180 System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 22, 2006 after 64 days
- Product code: NWB (Endoscope, Accessories, Narrow Band Spectrum)
- 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: 4 generations back to K931154 (1993). 17 ancestors in all.
158 later devices descend from it; 5 cite it directly.
5 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051645: Evis Exera 160A System, Olympus Medical Systems Corporation (2005) Summary page 2.
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA, Olympus America, Inc. (2002) Summary page 6.

## Most influential descendants
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own
- K112680: Evis Exera Iii Video System (2012), 57 descendants of its own
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 (2012), 34 descendants of its own
- K133538: Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type VA2, Visera Cysto-NE (2014), 25 descendants of its own
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 (2013), 19 descendants of its own

## Indications for use
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, XCYF TYPE VQ These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

Source page: https://510kreport.com/device/K062049
Methodology: https://510kreport.com/methodology