21 CFR 892.1990 — Transilluminator (Diaphanoscope)
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1990
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LEK | Transilluminator (Diaphanoscope) | 3 | 0 |
