Product code
NOT: Microscope, automated, image analysis, operator intervention
FDA product code · Class II · Pathology
Key facts
| Product code | NOT |
|---|---|
| Device | Microscope, automated, image analysis, operator intervention |
| Device class | Class II |
| Regulation number | 864.1860 |
| Review panel | Pathology |
| Medical specialty | Hematology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 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