# K043213: Kowa VX-10

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Oct 6, 2005 after 321 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: 2 generations back to K941234 (1995). 3 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM, Canon USA, Inc. (1998) Summary page 5.
- K954780: Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C, Kowa Optimed, Inc. (1995) Summary page 5.

## Most influential descendants
- K090115: Retina Camera TRC-NW7SF Mark II (2009), 30 descendants of its own
- 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

## Indications for use
Kowa VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.

Source page: https://510kreport.com/device/K043213
Methodology: https://510kreport.com/methodology