Cleared Traditional

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K192922) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192922 · Gentuity, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
127d
Days
Class 2
Risk

K192922 is an FDA 510(k) clearance for the Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Gentuity, LLC (Sudbury, US). The FDA issued a Cleared decision on February 20, 2020 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1560 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Gentuity, LLC devices

Submission Details

510(k) Number K192922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Mandell Horwitz Consultants, LLC
Diane Horwitz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 22
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K192922.
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458 · Abbott Medical · Jun 2021
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
K203578 · Perimeter Medical Imaging Ai, Inc. · Feb 2021
ApolloVue S100 Image System
K201552 · Apollo Medical Optics, Ltd. · Sep 2020
NvisionVLE Low-profile Optical Probe
K191117 · Ninepoint Medical, Inc. · Jul 2019
Ilumien Optis, Optis Integrated, Optis Mobile
K183320 · St. Jude Medical (Now Abbott Medical) · Apr 2019
OTIS Optical Coherence Tomography SYstem
K190404 · Perimeter Medical Imaging, Inc. · Mar 2019