# K111612: Digital Retinal Camera

- Pathway: 510(k) (Special)
- Applicant: Canon, Inc.
- Decided: Sep 14, 2011 after 97 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: 6 generations back to K941234 (1995). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102013: Digital Retinal Camera, Canon Inc. -Medical Equipment Group (2010) Summary page 1.
- K092565: Digital Retinal Camera CX-1, Canon Components, Inc. (2010) Summary page 1.

## Most influential descendants
- K123208: Digital Retinal Camera (2013), 2 descendants of its own
- K201273: ImageSPECTRUM (2020), 0 descendants of its own
- K201122: Canon non-mydriatic retinal camera CR series (2020), 0 descendants of its own

## Indications for use
The CR-2 Plus is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus has the following photography modes: color, red free & cobalt digital filter, and fundus autofluorecence (FAF).

Source page: https://510kreport.com/device/K111612
Methodology: https://510kreport.com/methodology