# K130289: TRC-NW8 Non-Mydriatic Retinal Camera

- Pathway: 510(k) (Special)
- Applicant: Topcon Corp.
- Decided: May 10, 2013 after 94 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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 2.

## Indications for use
The TRC-NWS 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 mnydriatic or without the use of a mydriatic.

Source page: https://510kreport.com/device/K130289
Methodology: https://510kreport.com/methodology