# K014274: Non-Mydriatic Fundus Camera, Model NM-1000

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Apr 17, 2002 after 111 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.
96 later devices descend from it; 5 cite it directly.
0 of 99 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 2.

## 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
- K023719: MP-1 Micro Perimeter (2002), 30 descendants of its own

## Indications for use
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is an ophthalmic camera that is indicated for use in capturing images of the retina and the anterior segment of the eye.

Source page: https://510kreport.com/device/K014274
Methodology: https://510kreport.com/methodology