Cleared Traditional

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

K242966 · Gentuity, LLC · Cardiovascular

Jan 2025

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K242966 is an FDA 510(k) clearance for the Gentuity? HF-OCT Imaging System with Vis-Rx Prime? Micro-Imaging Catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Gentuity, LLC (Sudbury, US). The FDA issued a Cleared decision on January 31, 2025, 127 days after receiving the submission on September 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K242966 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2024
Decision Date	January 31, 2025
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF