Cleared Special

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

K242239 · Gentuity, LLC · Cardiovascular

Aug 2024

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K242239 is an FDA 510(k) clearance for the HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)), a System, Imaging, Optical Coherence Tomography (oct) (Class II — Special Controls, product code NQQ), submitted by Gentuity, LLC (Sudbury, US). The FDA issued a Cleared decision on August 16, 2024, 17 days after receiving the submission on July 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K242239 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2024
Decision Date	August 16, 2024
Days to Decision	17 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	NQQ — System, Imaging, Optical Coherence Tomography (oct)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1560
Definition	This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.