FDA 510(k)

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

Numéro K : K242239 · 2024-08-16

Date de décision2024-08-16

Code produitNQQ

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Gentuity, LLC en tant que demandeur

K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

Dispositifs connexes (Code : NQQ)

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICAL K251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae Medical K251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant

Source officielle

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