# K093071: Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440

- Pathway: 510(k) (Traditional)
- Applicant: Fundus Photo, LLC
- Decided: Nov 17, 2010 after 413 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 K913929 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022164: Zeta Diagnostic Retinal Imaging System, Zeta Development Laboratories (2002) Summary page 1.

## Indications for use
The Fundus Photo Digital Imaging System Model CFD-440 Model is intended to capture, archive, and display digital images of the retina and surrounding areas of the eye.

Source page: https://510kreport.com/device/K093071
Methodology: https://510kreport.com/methodology