FDA product code · General, Plastic Surgery · Class 2
NQQ: System, Imaging, Optical Coherence Tomography (Oct)
NQQ is FDA's product code for "System, Imaging, Optical Coherence Tomography (Oct)": a Class 2 device classified under 21 CFR 892.1560, reviewed by the General, Plastic Surgery panel.
510(k) review time for NQQ
Across 23 510(k) clearances under NQQ decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 68 and 151 days, and 80% were decided within 187 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 68 |
| Median | 90 |
| 75th percentile | 151 |
| 80th percentile | 187 |
| 90th percentile | 253 |
| Slowest | 302 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
NQQ in the public FDA record
| 510(k) clearances, all years | 46 |
|---|
Counts of records, not of devices or events. Adverse event reports for NQQ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite NQQ
2 FDA recognized consensus standards cite NQQ, among them IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-37 Edition 3.0 2024-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-293 IEC 60601-2-37 Edition 2.1 2015 — Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- 12-380 IEC 60601-2-37 Edition 3.0 2024-07 — Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.