# K062021: Kowa VX-10I

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Nov 1, 2006 after 107 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091683: Kowa VX-10 a (2009), 7 descendants of its own
- K112330: Kowa VX-20 (2012), 6 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K062021
Methodology: https://510kreport.com/methodology