Product code
QNK: Optoacoustic imaging system
FDA product code · Class III · Radiology
Key facts
| Product code | QNK |
|---|---|
| Device | Optoacoustic imaging system |
| Device class | Class III |
| Review panel | Radiology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None 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