KOWA VK-2s— 510(k) K190056

Substantially Equivalent

Kowa Co. Ltd. Chofu

FDA 510(k) clearance K190056 for KOWA VK-2s, Substantially Equivalent on 2019-02-12. Applicant: Kowa Co. Ltd. Chofu. Device class: 2.

Clearance details

Applicant: Kowa Co. Ltd. Chofu
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-01-11
Decision date: 2019-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chofu City, JP

Download summary PDF View on FDA.gov ↗

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Recalls naming K190056

K-number listed on FDA's recall record

Z-0636-2021 — Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.Class II·Terminated·Kowa Optimed Inc·20201103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190056.

Data sourced from openFDA. This site is unofficial and independent of the FDA.