# K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corp.
- Decided: Feb 12, 2010 after 18 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). 9 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 38 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.
- K043213: Kowa VX-10, Kowa Co., Ltd. (2005) Summary page 3.
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera, Topcon Corp. (2004) Summary page 2.

## Most influential descendants
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K123460: TRC-NW300 Non-Mydriatic Retinal Camera (2013), 11 descendants of its own
- K161509: 3D OCT-1 Maestro (2016), 8 descendants of its own
- K170164: 3D OCT-1 Maestro (2017), 5 descendants of its own
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own

## Indications for use
The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F 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 Use of a mydriatic.

Source page: https://510kreport.com/device/K100207
Methodology: https://510kreport.com/methodology