# K982689: Winstation Retinal Imager

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Imaging Systems
- Decided: Oct 23, 1998 after 81 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022164: Zeta Diagnostic Retinal Imaging System (2002), 1 descendant of its own
- K093071: Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440 (2010), 0 descendants of its own

## Recalls of this device
- Dec 20, 2018 · Class II · Z-0939-2019: Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in eart

## Indications for use
The WinStation Retinal Imager™ has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segment (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner. The WinStation Retinal Imager™ will be operated by doctors and technicians in ophthalmic and optometric offices and other locations that are under the direction of a licensed physician in which it is appropriate to perform ocular imaging procedures. Fundus photography and slit lamp imaging is the standard of care for documentation of the patient’s eye.

Source page: https://510kreport.com/device/K982689
Methodology: https://510kreport.com/methodology