# K041546: Digital Fundus Camera, Model CF-60DSI

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Jun 23, 2004 after 14 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: 1 generation back to K946058 (1995). 1 ancestor in all.
80 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946058: 60 Fundus Camera CF-60UV, Canon USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K062295: Iri Integrated Retinal Imager (2006), 63 descendants of its own
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA (2010), 41 descendants of its own
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), 24 descendants of its own
- K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan (2009), 22 descendants of its own
- K101935: Centervue Digital Retinography System (2010), 21 descendants of its own

## Indications for use
DIGITAL FUNDUS CAMERA CF-60DSi is intended to be used for taking digital images of retina of human eye with a mydriatic.

Source page: https://510kreport.com/device/K041546
Methodology: https://510kreport.com/methodology