Data / Medical devices / United States / Gentuity, LLC

Gentuity, LLC: FDA-registered device maker in Sudbury, MA, United States, 3 510(k) clearances

Name: Gentuity, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gentuity, LLC is registered with the FDA (registration 3011578544) in Sudbury, MA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 31, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011578544
Address: 142 North Road Suite G, Sudbury, MA, United States, 01776
Owner or operator: Gentuity, LLC (10073861)
Roles: Complaint file establishment, Manufacturer
First device listed: May 15, 2020
Registered through: 2026
Brand names listed: Gentuity HF-OCT Imaging System, Gentuity® HF-OCT Imaging System, HF-OCT Imaging System with StentX Software, HF-OCT Imaging System with Vis-Rx Prime Micro-Imaging Catheter, Vis-Rx® Micro-Imaging Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Diagnostic	DQO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Optical Coherence Tomography, Intravascular Catheter	ORD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Imaging, Optical Coherence Tomography (Oct)	NQQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 31, 2025	K242966	Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter	DQO	Substantially Equivalent	Gentuity, LLC	accessdata.fda.gov
August 8, 2023	K230620	Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter	DQO	Substantially Equivalent	Gentuity, LLC	accessdata.fda.gov
February 20, 2020	K192922	Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter	NQQ	Substantially Equivalent	Gentuity, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 23, 2026	98619	Class II	Ongoing	Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13	The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements duri	accessdata.fda.gov

Compare with other makers

Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.