# K031629: Canon Non-Mydriatic Retinal Camera, Model CR-Dgi

- Pathway: 510(k) (Traditional)
- Applicant: Canon USA, Inc.
- Decided: Jun 6, 2003 after 10 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 K941234 (1995). 2 ancestors in all.
92 later devices descend from it; 2 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM, Canon USA, Inc. (1998) Summary page 1.

## Most influential descendants
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera (2004), 79 descendants of its own
- K062295: Iri Integrated Retinal Imager (2006), 63 descendants of its own
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA (2010), 41 descendants of its own
- K090115: Retina Camera TRC-NW7SF Mark II (2009), 30 descendants of its own
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F (2010), 28 descendants of its own

## Indications for use
Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.

Source page: https://510kreport.com/device/K031629
Methodology: https://510kreport.com/methodology