# K022164: Zeta Diagnostic Retinal Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Zeta Development Laboratories
- Decided: Jul 26, 2002 after 23 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: 3 generations back to K913929 (1991). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982689: Winstation Retinal Imager, Ophthalmic Imaging Systems (1998) Summary page 1.
- K980295: Ophthavision Imaging System, Mrp Group, Inc. (1998) Summary page 1.
- K971685: Imagescape Digital Retinal Image System, Tomey Corporation USA (1997) Summary page 1.
- K870039: Imagenet Digital Ophthalmic Imaging System, Par Microsystems Corp. (1987) Summary page 1.

## Most influential descendants
- K093071: Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440 (2010), 0 descendants of its own

## Indications for use
The Zeta Diagnostic Retinal Imaging System is intended to be used to capture, archive, recall and display black and white, and color images of the retina captured using an ophthalmic camera during angiography non-invasively.

Source page: https://510kreport.com/device/K022164
Methodology: https://510kreport.com/methodology