# K080180: Modification to Retinal Function Imager (Rfi)

- Pathway: 510(k) (Traditional)
- Applicant: Optical Imaging, Ltd.
- Decided: Jun 11, 2008 after 139 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 K943955 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062416: Retinal Functional Imager (Rfi), Optical Imaging, Ltd. (2006) Summary page 2.

## Most influential descendants
- K193319: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System (2020), 0 descendants of its own

## Indications for use
The Retinal Functional Imager (RFI) is intended to observe, capture, display, and store images of patients' fundus (retina) under mydriatic conditions to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Source page: https://510kreport.com/device/K080180
Methodology: https://510kreport.com/methodology