# K101935: Centervue Digital Retinography System

- Pathway: 510(k) (Traditional)
- Applicant: Centervue S.P.A.
- Decided: Oct 27, 2010 after 107 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: 6 generations back to K941234 (1995). 18 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan, Ophthalmic Imaging Systems (2009) Summary page 2.
- K070231: ORION, Nidek Technologies Srl (2007) Summary page 2.

## Most influential descendants
- K142047: EIDON (2014), 8 descendants of its own
- K122572: Icam Fundus Camera (2013), 8 descendants of its own
- K182199: NFC-700 non-mydriatic auto fundus camera (2019), 3 descendants of its own
- K180526: Eidon FA (2018), 2 descendants of its own
- K180306: Nexy (2018), 2 descendants of its own

## Indications for use
The CenterVue Digital Retinography System ORS is intended for taking digital images of a human retina without the use of a mydriatic agent.

Source page: https://510kreport.com/device/K101935
Methodology: https://510kreport.com/methodology