# K100345: Systems Integration Model: Endoalpha

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corporation
- Decided: Mar 22, 2010 after 45 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: 7 generations back to K801623 (1980). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051613: Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 3, Olympus Medical Systems Corporation (2005) Summary page 5.

## Most influential descendants
- K102763: Systems Integration (2011), 0 descendants of its own

## Indications for use
The Systems Integration ENDOALPHA 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/K100345
Methodology: https://510kreport.com/methodology