# K090466: Digital Retinal Camera, CR-1 Mark II

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Mar 23, 2009 after 30 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: 4 generations back to K941234 (1995). 7 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080883: CR-1, Canon, Inc. (2008) Summary page 1.

## Most influential descendants
- K102013: Digital Retinal Camera (2010), 4 descendants of its own
- K111612: Digital Retinal Camera (2011), 3 descendants of its own
- 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 device is intended to be used for taking digital images of retina of human eye without a mydriatic.

Source page: https://510kreport.com/device/K090466
Methodology: https://510kreport.com/methodology