# K180526: Eidon FA

- Pathway: 510(k) (Traditional)
- Applicant: Centervue S.P.A.
- Decided: Jul 16, 2018 after 139 days
- Product code: MYC (Ophthalmoscope, Laser, Scanning)
- Device class: 2
- Regulation: 21 CFR 886.1570
- 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 K941234 (1995). 34 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142047: EIDON, Centervue S.P.A. (2014) Summary page 5.
- K112330: Kowa VX-20, Kowa Co., Ltd. (2012) Summary page 7.
- K172649: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor, Heidelberg Engineering GmbH (2017) Summary page 7.

## Most influential descendants
- K211328: Eidon FA, Eidon, Eidon AF, Eidon Uwfl (2021), 1 descendant of its own
- K241931: OcuMet Beacon  (OCUB100) (2025), 0 descendants of its own

## Indications for use
The CenterVue EIDON FA is a confocal scanning ophthalmoscope indicated for color, infrared and auto-fluorescence imaging and fluorescein angiography of a human retina with or without the use of a mydriatic agent.

Source page: https://510kreport.com/device/K180526
Methodology: https://510kreport.com/methodology