FDA product code NQQ: System, Imaging, Optical Coherence Tomography (Oct)
NQQ is the FDA product code for system, imaging, optical coherence tomography (oct). It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the General and Plastic Surgery panel. FDA has cleared 46 510(k) submissions under NQQ, 14 in the last five years, from 21 different applicants. The average 510(k) review took 116 days (median 90); 142 days on average over the last three years. FDA has posted 3 recalls for NQQ devices.
Definition
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | Class II |
| Regulation | 21 CFR 892.1560 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NQQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
| 2018 | 2 | 49 |
| 2019 | 3 | 81 |
| 2020 | 2 | 106 |
| 2021 | 2 | 96 |
| 2023 | 3 | 139 |
| 2024 | 2 | 72 |
| 2025 | 8 | 154 |
| 2026 | 1 | 199 |
Compare with all 510(k) review times · Search every NQQ clearance
Top NQQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ninepoint Medical, Inc. | 8 | 2019-07-19 |
| Lightlab Imaging, Inc. | 8 | 2016-06-29 |
| Spectrawave, Inc. | 5 | 2025-12-15 |
| ABBOTT MEDICAL | 3 | 2026-04-24 |
| Perimeter Medical Imaging, Inc. | 3 | 2019-03-26 |
16 more applicants have NQQ clearances. See the full list in Caduvo.
Most recent NQQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253459 | ABBOTT MEDICAL | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | 2026-04-24 | 199 |
| K251730 | Leadoptik, Inc. | LIA Console (542-7) | 2025-12-19 | 196 |
| K253101 | Spectrawave, Inc. | HyperVue Imaging System - Integrated | 2025-12-15 | 82 |
| K252851 | Damae Medical | deepLive (OSP12 + DMS) | 2025-10-07 | 29 |
| K251198 | Spectrawave, Inc. | HyperVue Software | 2025-07-16 | 90 |
Recalls for NQQ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-04-11.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NQQ?
NQQ is the FDA product code for system, imaging, optical coherence tomography (oct). It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the General and Plastic Surgery panel.
What device class is NQQ?
Class II, regulation 21 CFR 892.1560. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQQ?
Across 46 cleared submissions the average was 116 days from receipt to decision (median 90).
Which companies have the most NQQ clearances?
Ninepoint Medical, Inc. (8); Lightlab Imaging, Inc. (8); Spectrawave, Inc. (5); ABBOTT MEDICAL (3); Perimeter Medical Imaging, Inc. (3).
Have NQQ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2018-04-11.
Next steps
- Run an FDA pathway report with predicate devices for product code NQQ
- Run a recall and safety report across every NQQ manufacturer
- Watch product code NQQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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