# K141325: TRC-NW8F Plus Non-Mydriatic Retinal Camera

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corp.
- Decided: Oct 23, 2014 after 156 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: 6 generations back to K941234 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F, Topcon Corp. (2010) Summary page 4.
- K123101: TRC-50DX Retinal Camera, Topcon Medical Systems, Inc. (2013) Summary page 4.

## Indications for use
The Non-Mydriatic Retinal Camera TRC-NW8F plus is 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, with the use of a mydriatic or without the use of a mydriatic.

Source page: https://510kreport.com/device/K141325
Methodology: https://510kreport.com/methodology