Product code
QJG: Device system, imaging, tympanic membrane and middle ear
FDA product code · Class II · Ear Nose & Throat
Key facts
| Product code | QJG |
|---|---|
| Device | Device system, imaging, tympanic membrane and middle ear |
| Device class | Class II |
| Regulation number | 892.1560 |
| Review panel | Ear Nose & Throat |
| Medical specialty | Radiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None 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