# K180306: Nexy

- Pathway: 510(k) (Traditional)
- Applicant: Next Sight Srl
- Decided: Jun 8, 2018 after 126 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- 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 K941234 (1995). 24 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101935: Centervue Digital Retinography System, Centervue S.P.A. (2010) Summary page 6.
- K120982: Digital Eye-Fundus Camera, Medimaging Integrated Solutions, Inc. (Miis) (2012) Summary page 6.

## Most influential descendants
- K250683: Resolve Fundus Camera (2025), 0 descendants of its own
- K202221: VX650 (2021), 0 descendants of its own

## Indications for use
Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.

Source page: https://510kreport.com/device/K180306
Methodology: https://510kreport.com/methodology