# K101628: Kowa Nonmyd WX

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Jan 26, 2011 after 230 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: 4 generations back to K941234 (1995). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053026: Kowa Nonmyd 7, Kowa Nonmyd a-D, Kowa Co., Ltd. (2005) Summary page 1.
- K973533: Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF), Nidek, Inc. (1997) Summary page 1.

## Most influential descendants
- K191945: KOWA nonmyd 8 (2019), 0 descendants of its own
- K132987: Cobra Fundus Camera (2014), 0 descendants of its own

## Indications for use
KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to anl image filing device through serial interface.

Source page: https://510kreport.com/device/K101628
Methodology: https://510kreport.com/methodology