# K062416: Retinal Functional Imager (Rfi)

- Pathway: 510(k) (Traditional)
- Applicant: Optical Imaging, Ltd.
- Decided: Nov 17, 2006 after 92 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: 2 generations back to K943955 (1994). 4 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K954780: Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C, Kowa Optimed, Inc. (1995) Summary page 2.
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001) Summary page 2.
- K992606: Canon Laser Blood Flowmeter (CLBF) Model 100, Canon USA, Inc. (2000) Summary page 2.
- K943955: Retina Flowmeter, Heidelberg Engineering (1994) Summary page 2.

## Most influential descendants
- K080180: Modification to Retinal Function Imager (Rfi) (2008), 1 descendant of its own
- K193319: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System (2020), 0 descendants of its own
- K153239: LSFG-Navi (2016), 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 with the information of blood flow (velocity) and path of flow in a retinal vessel, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

Source page: https://510kreport.com/device/K062416
Methodology: https://510kreport.com/methodology