# K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM

- Pathway: 510(k) (Traditional)
- Applicant: Canon USA, Inc.
- Decided: May 6, 1998 after 103 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: 1 generation back to K941234 (1995). 1 ancestor in all.
120 later devices descend from it; 5 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941234: Non-Mydriatic Retinal Camera, Canon USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000 (2002), 96 descendants of its own
- K031629: Canon Non-Mydriatic Retinal Camera, Model CR-Dgi (2003), 92 descendants of its own
- 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

## Indications for use
Taking pictures of retina of human eye.

Source page: https://510kreport.com/device/K980246
Methodology: https://510kreport.com/methodology