FDA 510(k)

Gentuity HF-OCT影像系統搭配Vis-Rx微影像導管

K 號：K192922 · 2020-02-20

決定日期2020-02-20

產品代碼NQQ

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Gentuity, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242966Gentuity® 高頻率OCT影像系統搭配Vis-Rx Prime® 微影像導管 K242239HF-OCT影像系統搭配Vis-RX微影像導管（G10（HF-OCT控制台），G30（Vis-Rx微影像導管））K230620Gentuity® 高頻率OCT影像系統搭配Vis-Rx® 微影像導管

相關器械（代碼：NQQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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