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FDA 510(k)

HF-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））

K号: K242239 · 2024-08-16

申请人Gentuity, LLC
决定日期2024-08-16
产品代码NQQ
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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K230620Gentuity® HF-OCT 成像系统，配备 Vis-Rx® 微成像导管K192922Gentuity HF-OCT 成像系统，配备 Vis-Rx 微成像导管

相关器械（代码：NQQ）

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。

K253459OPTIS 移动 Next 成像系统 (1014932)；OPTIS 集成 Next 成像系统 (1014933)；Ultreon 3.0 软件升级套件 (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™成像系统 - 集成Spectrawave, Inc.K252851deepLive（OSP12 + DMS）Damae MedicalK251198HyperVue™软件Spectrawave, Inc.K250684OPUSWAVE 双传感器成像系统Terumo Cardiovascular Systems Thi Plant

官方来源

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