# K091098: Kowagenesis-DF

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Aug 7, 2009 after 113 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 K050271 (2005). 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)
- K050271: Kowa Genesis-D Hand-Held Retinal Camera, Kowa Co., Ltd. (2005) Summary page 2.

## Most influential descendants
- K201325: Optomed Smartscope M5 with Optomed Smartscope FA (2020), 0 descendants of its own

## Indications for use
KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.

Source page: https://510kreport.com/device/K091098
Methodology: https://510kreport.com/methodology