# K190056: KOWA VK-2s

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co. Ltd. Chofu
- Decided: Feb 12, 2019 after 32 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082767 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173689: Ophthalmic Software Platform RX, Canon Inc. -Medical Equipment Group (2018) Summary page 5.
- K083387: Modification to Kowa Nonmyd Alpha-Diii, Kowa Co., Ltd. (2009) Summary page 5.

## Recalls of this device
- Nov 3, 2020 · Class II · Z-0636-2021: It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a potential for all pa

## Indications for use
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.

Source page: https://510kreport.com/device/K190056
Methodology: https://510kreport.com/methodology