Cleared Traditional

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

K192922 · Gentuity, LLC · Cardiovascular

Feb 2020

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K192922 is an FDA 510(k) clearance for the Gentuity HF-OCT Imaging System with 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 February 20, 2020, 127 days after receiving the submission on October 16, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K192922 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 2019
Decision Date	February 20, 2020
Days to Decision	127 days
Submission Type	Traditional
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.