NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX— 510(k) K113451

Name: FDA 510(k) clearance K113451
Creator: U.S. Food and Drug Administration
Published: 2012-05-08

Substantially Equivalent

Nidek Technologies Srl

FDA 510(k) clearance K113451 for NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX, Substantially Equivalent on 2012-05-08. Applicant: Nidek Technologies Srl. Device class: 2.

Clearance details

Applicant: Nidek Technologies Srl
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2011-11-21
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albignasego (Padova), IT

Download summary PDF View on FDA.gov ↗

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Recalls naming K113451

K-number listed on FDA's recall record

Z-1980-2014 — Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.Class II·Terminated·Nidek Inc·20140616
Z-2046-2013 — NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.Class II·Terminated·Nidek Inc·20130801

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113451.

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