# K141481: TRC-NW400 Non-Mydriatic Retinal Camera

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corporation
- Decided: Sep 17, 2014 after 105 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: 7 generations back to K941234 (1995). 11 ancestors in all.
1 later device descends 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)
- K123460: TRC-NW300 Non-Mydriatic Retinal Camera, Topcon Medical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K221111: Non-Mydriatic Retinal Camera NW500 (2022), 0 descendants of its own

## Indications for use
The TRC-NW400 intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, without use of a mydriatic.

Source page: https://510kreport.com/device/K141481
Methodology: https://510kreport.com/methodology