What is FDA product code NQQ?

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

Radiology › DiagnosticSystem, Imaging, Optical Coherence Tomography (Oct)

Gentuity HF-OCT Imaging System

Name: Gentuity HF-OCT Imaging System
Brand: Gentuity HF-OCT Imaging System

Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1).

Chinese manufacturers registered for FDA product code NQQ
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Shenzhen Vivolight Medical Device&Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	4

Record

Regulatory record for Gentuity HF-OCT Imaging System
Listed by	Gentuity, LLC, United States
FDA product code	NQQ
Device type	System, Imaging, Optical Coherence Tomography (Oct)
Device class	Class 2
Regulation	21 CFR 892.1560
Establishment	Complaint-file establishment, Manufacturer
510(k)	K192922
Record published	2021-06-22
Record revised	2026-03-16 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Gentuity HF-OCT Imaging System
Catalogue number	Size	Status
SW 23.3.13		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Optis™	St. Jude Medical	13
Optis™	Lightlab Imaging, Inc.	11
Luminscan(TM) Disposable Imaging Kit	Micro-Tech (Nanjing) Co., Ltd.	9
Ilumien™	Lightlab Imaging, Inc.	6
Cornaris Intravascular Imaging System	Shenzhen Vivolight Medical Device&Technology Co., Ltd.	2
VivoSight	Michelson Diagnostics Ltd	2
AptiVue™	Lightlab Imaging, Inc.	2
Pantheris	Avinger, Inc.	2
NvisionVLE Imaging Console	Ninepoint Medical, Inc.	1
NvisionVLE Imaging Console Refurbished	Ninepoint Medical, Inc.	1
NvisionVLE Marking Probe 17mm	Ninepoint Medical, Inc.	1
NvisionVLE Low Profile Imaging Probe, 20mm Working Distance	Ninepoint Medical, Inc.	1

Showing 12 of 56. All products under System, Imaging, Optical Coherence Tomography (Oct)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242239	2024-08-16
K192922	2020-02-20

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Gentuity HF-OCT Imaging System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Gentuity, LLC	UDI-DI	2026-03-23	Class II	Device Design	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 infor	184 units (28 US, 156 OUS)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.