# K092565: Digital Retinal Camera CX-1

- Pathway: 510(k) (Traditional)
- Applicant: Canon Components, Inc.
- Decided: Mar 18, 2010 after 210 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: 4 generations back to K941234 (1995). 7 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063717: CF-1, Canon, Inc. (2007) Summary page 1.
- K080883: CR-1, Canon, Inc. (2008) Summary page 1.

## Most influential descendants
- K112330: Kowa VX-20 (2012), 6 descendants of its own
- K111612: Digital Retinal Camera (2011), 3 descendants of its own
- K200254: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (2020), 2 descendants of its own
- K180526: Eidon FA (2018), 2 descendants of its own
- K123101: TRC-50DX Retinal Camera (2013), 2 descendants of its own

## Indications for use
The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.

Source page: https://510kreport.com/device/K092565
Methodology: https://510kreport.com/methodology