# K083387: Modification to Kowa Nonmyd Alpha-Diii

- Pathway: 510(k) (Special)
- Applicant: Kowa Co., Ltd.
- Decided: Jan 16, 2009 after 60 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: 1 generation back to K082767 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082767: Kowa Nonmyd Alpha-Diii, Kowa Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K190056: KOWA VK-2s (2019), 0 descendants of its own

## Indications for use
KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface

Source page: https://510kreport.com/device/K083387
Methodology: https://510kreport.com/methodology