# K221111: Non-Mydriatic Retinal Camera NW500

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corporation
- Decided: Aug 29, 2022 after 136 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: 8 generations back to K941234 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141481: TRC-NW400 Non-Mydriatic Retinal Camera, Topcon Corporation (2014) Summary page 4.

## Indications for use
The Non-Mydriatic Retinal Camera NWS00 intended for use in capturing images of the retina and presenting the data to the eye care professional, without the use of a mydriatic.

Source page: https://510kreport.com/device/K221111
Methodology: https://510kreport.com/methodology