FDA 510(k)

ゲンティュイ HF-OCT画像システムおよびVis-Rxマイクロイメージングカテーテル

K番号: K192922 · 2020-02-20

決定日2020-02-20

製品コードNQQ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてGentuity, LLCを記載するその他の記録

K242966Gentuity® HF-OCT画像システムおよびVis-Rx Prime®マイクロ画像カテーテル K242239HF-OCT画像システムおよびVis-RXマイクロ画像カテーテル（G10（HF-OCTコンソール）、G30（Vis-Rxマイクロ画像カテーテル））K230620Gentuity® HF-OCT画像システムおよびVis-Rx®マイクロ画像カテーテル

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