Product code
OLQ: Cross-sectional mammographic xray system
FDA product code · Class III · Radiology
Key facts
| Product code | OLQ |
|---|---|
| Device | Cross-sectional mammographic xray system |
| Device class | Class III |
| Review panel | Radiology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 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