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FDA 510(k)

HF-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））

K 號：K242239 · 2024-08-16

申請人Gentuity, LLC
決定日期2024-08-16
產品代碼NQQ
諮詢委員會RA
決定相當於

器材摘要

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (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 2024-08-16 under 510(k) number K242239. 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 HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))?

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Gentuity, LLC. The 510(k) number is K242239.

When did HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) receive FDA 510(k) clearance?

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) received FDA 510(k) clearance on 2024-08-16, under 510(k) number K242239.

Who is the listed applicant for HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (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 HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))?

The FDA product code for HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) is NQQ.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K230620Gentuity® 高頻率OCT影像系統搭配Vis-Rx® 微影像導管K192922Gentuity HF-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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