(a) 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.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval (PMA) or notice of completion of a product development protocol (PDP) is required. The effective date of the requirement for premarket approval has not been established. See § 892.3.