LEK · Transilluminator (Diaphanoscope)
Radiology · 21 CFR 892.1990 · Class 3
Overview
| Product Code | LEK |
|---|---|
| Device Name | Transilluminator (Diaphanoscope) |
| Regulation | 21 CFR 892.1990 |
| Device Class | Class 3 |
| Review Panel | Radiology |
Identification
A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
