# K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corp.
- Decided: Nov 5, 2004 after 165 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: 3 generations back to K941234 (1995). 4 ancestors in all.
79 later devices descend from it; 5 cite it directly.
0 of 84 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.
- K031629: Canon Non-Mydriatic Retinal Camera, Model CR-Dgi, Canon USA, Inc. (2003) Summary page 1.
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000, Nidek, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), 24 descendants of its own

## Indications for use
The Topcon Model TRC-NW200 Non-Mydriatic Camera is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eyecare professional, without the use of a mydriatic.

Source page: https://510kreport.com/device/K041367
Methodology: https://510kreport.com/methodology