# K123101: TRC-50DX Retinal Camera

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Systems, Inc.
- Decided: Jun 5, 2013 after 244 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: 5 generations back to K941234 (1995). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090115: Retina Camera TRC-NW7SF Mark II, Topcon Corp. (2009) Summary page 2.
- K092565: Digital Retinal Camera CX-1, Canon Components, Inc. (2010) Summary page 2.

## Most influential descendants
- K173119: DRI OCT Triton (2018), 0 descendants of its own
- K141325: TRC-NW8F Plus Non-Mydriatic Retinal Camera (2014), 0 descendants of its own

## Indications for use
The TRC-50DX Retinal Camera is intended for use in capturing images of the retina and anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic.

Source page: https://510kreport.com/device/K123101
Methodology: https://510kreport.com/methodology