# K123460: TRC-NW300 Non-Mydriatic Retinal Camera

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Feb 6, 2013 after 89 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.
11 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera, Topcon Corp. (2004) Summary page 2.
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F, Topcon Corp. (2010) Summary page 2.

## Most influential descendants
- K161509: 3D OCT-1 Maestro (2016), 8 descendants of its own
- K170164: 3D OCT-1 Maestro (2017), 5 descendants of its own
- K231222: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (2023), 3 descendants of its own
- K171370: IMAGEnet 6 Ophthalmic Data System (2017), 3 descendants of its own
- K233561: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (2024), 2 descendants of its own

## Indications for use
The TRC-NW3OO 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 the use of a maydriatic.

Source page: https://510kreport.com/device/K123460
Methodology: https://510kreport.com/methodology