Cleared Traditional

K230620 - Gentuity HF-OCT Imaging System with Vis...

K230620 is an FDA 510(k) clearance for Gentuity HF-OCT Imaging System with Vis..., manufactured by Gentuity, LLC. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K230620 · Gentuity, LLC · Cardiovascular device
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Aug 2023
Decision
155d
Days
Class 2
Risk

K230620 is an FDA 510(k) clearance for the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Gentuity, LLC (Sudbury, US). The FDA issued a Cleared decision on August 8, 2023 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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

FDA 510(k) Submission Details - K230620

510(k) Number K230620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2023
Decision Date August 08, 2023
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Peers - DQO Catheter, Intravascular, Diagnostic

All 319
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