Facility

GENTUITY, LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011578544
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	142 North Road Sudbury, MA, US 01776
Registration status	Active · expires 2026
Parent company	Gentuity, LLC (owner-operator 10073861)
Brand names	HF-OCT Imaging System with Vis-Rx Prime Micro-Imaging Catheter

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (2)

System, Imaging, Optical Coherence Tomography (Oct)
Product code NQQ (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560
Catheter, Intravascular, Diagnostic
Product code DQO (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1200

Recalls & enforcement

Class IIOngoing2026-03-23
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 miti…

FDA inspections (2)

OAI2026-03-05
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-09-16
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2026-07-02
Warning Letter (opens in a new tab) · Sudbury Massachusetts

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “GENTUITY, LLC (FEI 3011578544) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011578544-gentuity-llc/

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