# K112330: Kowa VX-20

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Feb 16, 2012 after 188 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). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091683: Kowa VX-10 a, Kowa Co., Ltd. (2009) Summary page 1.
- K092565: Digital Retinal Camera CX-1, Canon Components, Inc. (2010) Summary page 1.

## Most influential descendants
- K200254: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (2020), 2 descendants of its own
- K180526: Eidon FA (2018), 2 descendants of its own
- K231230: Optina-4C (MHRC-C1N) (2023), 1 descendant of its own
- K211328: Eidon FA, Eidon, Eidon AF, Eidon Uwfl (2021), 1 descendant of its own
- K250770: Optina-4C (MHRC-C1N) (2025), 0 descendants of its own

## Indications for use
The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.

Source page: https://510kreport.com/device/K112330
Methodology: https://510kreport.com/methodology