# K090115: Retina Camera TRC-NW7SF Mark II

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Corp.
- Decided: Jun 30, 2009 after 160 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: 4 generations back to K941234 (1995). 8 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946058: 60 Fundus Camera CF-60UV, Canon USA, Inc. (1995) Summary page 3.
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera, Topcon Corp. (2004) Summary page 3.
- K043213: Kowa VX-10, Kowa Co., Ltd. (2005) Summary page 3.

## Most influential descendants
- K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F (2010), 28 descendants of its own
- 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

## Indications for use
Retina Camera TRC-NW7SF MARK II system 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 or without the use of mydriatic.

Source page: https://510kreport.com/device/K090115
Methodology: https://510kreport.com/methodology