# K051613: Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 3

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corporation
- Decided: Aug 15, 2005 after 59 days
- Product code: ODA (Endoscopic Central Control Unit)
- 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: 6 generations back to K801623 (1980). 26 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041494: Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 2, Olympus Corporation (2004) Summary page 2.

## Most influential descendants
- K100852: Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 (2010), 2 descendants of its own
- K123426: Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS (2013), 1 descendant of its own
- K100345: Systems Integration Model: Endoalpha (2010), 1 descendant of its own
- K151737: MedicVOD System (2016), 0 descendants of its own
- K102763: Systems Integration (2011), 0 descendants of its own

## Indications for use
The Olympus Integrated Endosurgery System EndoALPHA (Control Unit for Endosurgery UCES-2) has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.

Source page: https://510kreport.com/device/K051613
Methodology: https://510kreport.com/methodology