FDA 510(k)

Gentuity HF-OCT 成像系统，配备 Vis-Rx 微成像导管

K号: K192922 · 2020-02-20

决定日期2020-02-20

产品代码NQQ

咨询委员会RA

决定实质等同

器械摘要

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Gentuity, LLC. It received FDA 510(k) clearance on 2020-02-20 under 510(k) number K192922. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter?

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is a medical device that received FDA 510(k) clearance on 2020-02-20. The listed applicant is Gentuity, LLC. The 510(k) number is K192922.

When did Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter receive FDA 510(k) clearance?

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter received FDA 510(k) clearance on 2020-02-20, under 510(k) number K192922.

Who is the listed applicant for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter?

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

What is the FDA product code for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter?

The FDA product code for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is NQQ.

列明Gentuity, LLC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。

K242966Gentuity® HF-OCT 成像系统，配备 Vis-Rx Prime® 微成像导管 K242239HF-OCT 成像系统与 Vis-RX 微成像导管（G10（HF-OCT 控制台），G30（Vis-Rx 微成像导管））K230620Gentuity® HF-OCT 成像系统，配备 Vis-Rx® 微成像导管

官方来源

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