FDA 510(k)

Image Filing Software NAVIS-EX

K号: K181345 · 2018-07-19

决定日期2018-07-19

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

Image Filing Software NAVIS-EX is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2018-07-19 under 510(k) number K181345. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Image Filing Software NAVIS-EX?

Image Filing Software NAVIS-EX is a medical device that received FDA 510(k) clearance on 2018-07-19. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K181345.

When did Image Filing Software NAVIS-EX receive FDA 510(k) clearance?

Image Filing Software NAVIS-EX received FDA 510(k) clearance on 2018-07-19, under 510(k) number K181345.

Who is the listed applicant for Image Filing Software NAVIS-EX?

The FDA 510(k) record lists Nidek Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Filing Software NAVIS-EX?

The FDA product code for Image Filing Software NAVIS-EX is NFJ.

列明Nidek Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K221320扫描激光检眼镜Mirante [SLO/OCT型号]带图像归档软件NAVIS-EX；扫描激光检眼镜Mirante [SLO型号]带图像归档软件NAVIS-EX K203130眼科Yag激光系统YC-200 K192045眼科Yag激光系统YC-200 K190198Microperimeter MP-3, Microperimeter MP-3 Type S K173980Specular 显微镜 CEM-530 K170302黄色激光光凝器 YLC-500

查看所有 11 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。