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FDA 510(k)

眼科软件平台RX

K号: K173689 · 2018-02-23

决定日期2018-02-23
产品代码NFJ
咨询委员会RA
决定实质等同

器械摘要

Ophthalmic Software Platform RX is the device name listed in this FDA 510(k) record. The listed applicant is Canon Inc. -Medical Equipment Group. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173689. 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 Ophthalmic Software Platform RX?

Ophthalmic Software Platform RX is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Canon Inc. -Medical Equipment Group. The 510(k) number is K173689.

When did Ophthalmic Software Platform RX receive FDA 510(k) clearance?

Ophthalmic Software Platform RX received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173689.

Who is the listed applicant for Ophthalmic Software Platform RX?

The FDA 510(k) record lists Canon Inc. -Medical Equipment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ophthalmic Software Platform RX?

The FDA product code for Ophthalmic Software Platform RX is NFJ.

相关临床试验

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列明Canon Inc. -Medical Equipment Group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。

相关器械(代码:NFJ)

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。

官方来源

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