# K201122: Canon non-mydriatic retinal camera CR series

- Pathway: 510(k) (Special)
- Applicant: Canon, Inc.
- Decided: Jul 23, 2020 after 87 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: 8 generations back to K941234 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123208: Digital Retinal Camera, Canon Inc. -Medical Equipment Group (2013) Summary page 4.

## Indications for use
Canon non-mydriatic retinal camera CR series (CR-2 plus AF and CR-2 AF) is intended to be used for taking digital images of the retina of the human eye without mydriatic. The CR-2 plus AF has the following photography modes: color, red-free, cobalt digital and fundus autofluorescence (FAF). The CR-2 AF has the following photography modes: color, red-free, cobalt digital and additional infrared photography for anterior segment.

Source page: https://510kreport.com/device/K201122
Methodology: https://510kreport.com/methodology