# K020888: Fundus Autoimager

- Pathway: 510(k) (Traditional)
- Applicant: Visual Pathways, Inc.
- Decided: Nov 7, 2002 after 234 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 K870039 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001)
- K870039: Imagenet Digital Ophthalmic Imaging System, Par Microsystems Corp. (1987) Summary page 1.

## Indications for use
The Fundus AutoImagerTM is an automated ocular fimdus imaging device that allows for the rapid capture, storage, manipulation and transmission of images of the eye, especially the retina area, as an aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Source page: https://510kreport.com/device/K020888
Methodology: https://510kreport.com/methodology