# K102763: Systems Integration

- Pathway: 510(k) (Special)
- Applicant: Olympus Medical Systems Corporation
- Decided: Feb 15, 2011 after 144 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: 8 generations back to K801623 (1980). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100345: Systems Integration Model: Endoalpha, Olympus Medical Systems Corporation (2010) Summary page 2.

## Indications for use
SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 The Systems Integration ENDOALPHA has been designed to be used with an Olympus endloscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment. UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943 This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.

Source page: https://510kreport.com/device/K102763
Methodology: https://510kreport.com/methodology