# K130453: Excelsior

- Pathway: 510(k) (Traditional)
- Applicant: Eyekor, LLC
- Decided: Apr 2, 2013 after 39 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K896095 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093313: Synergy, Topcon Medical Systems, Inc. (2009) Summary page 2.
- K090439: FORUM, Carl Zeiss Meditec, Inc. (2009) Summary page 2.

## Most influential descendants
- K220929: Excelsior (2022), 0 descendants of its own

## Indications for use
The EXCELSIOR Software is intended for use in importing, processing, measurement, analysis and storage of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials.

Source page: https://510kreport.com/device/K130453
Methodology: https://510kreport.com/methodology