NQQClass II

System, Imaging, Optical Coherence Tomography (Oct)

21 CFR 892.1560 / Radiology

NQQ is the FDA product code for System, Imaging, Optical Coherence Tomography (Oct), a class II device type, regulated under 21 CFR 892.1560. FDA's definition for this code reads: "This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging". As of 2026-09-10, FDA records hold 46 510(k) clearances under this code, the most recent dated 2026-04-24, and 3 recalls.

Classification record

Product code: NQQ
Device name: System, Imaging, Optical Coherence Tomography (Oct)
FDA definition: This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Regulation: 21 CFR 892.1560
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 46
Ingested recalls: 3

Clearances, product code NQQ

By decision year

46 clearances under product code NQQ with a decision year between 2004 and 2026, 2025 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code NQQ by decision year
Year	Clearances
2004	2
2010	3
2011	2
2012	1
2013	2
2014	2
2015	5
2016	5
2017	1
2018	2
2019	3
2020	2
2021	2
2023	3
2024	2
2025	8
2026	1

Applicants with the most clearances

Product code NQQ

Applicants holding the most 510(k) clearances under product code NQQ
Applicant	Clearances
Lightlab Imaging, Inc.	8
Ninepoint Medical, Inc.	8
Spectrawave, Inc.	5
Abbott Medical	3
Perimeter Medical Imaging, Inc.	3
Damae Medical	2
Gentuity, LLC	2
Michelson Diagnostics Ltd	2
AGFA Healthcare Corp.	1
Apollo Medical Optics, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order