Product code
NQQ: System, imaging, optical coherence tomography (oct)
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | NQQ |
|---|---|
| Device | System, imaging, optical coherence tomography (oct) |
| Device class | Class II |
| Regulation number | 892.1560 |
| Review panel | General & Plastic Surgery |
| Medical specialty | Radiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database