Is this your brand? Sign in to claim ownership.

Gentuity, LLC

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Gentuity HF-OCT Imaging System	Gentuity Imaging System G10-01 K192922	FDA UDI	Class II	Active
Gentuity	Gentuity Review Station	FDA UDI	Class II	Active
Vis-Rx Prime	G31	FDA UDI	Class II	Active
Vis-Rx	US Catheter Kit G30-01	FDA UDI	Class II	Active
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter	K242966	FDA 510(k)	Class II	Active
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter	K192922	FDA 510(k)	Class II	Active
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter	K230620	FDA 510(k)	Class II	Active
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))	K242239	FDA 510(k)	Class II	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 23, 2026	Z-1823-2026	—	open, classified	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 during OCT imaging.