21 C.F.R. § 892.1990 Transilluminator for breast evaluation.
Title 21 - Food and Drugs
(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. [60 FR 36639, July 18, 1995]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1990 Transilluminator for breast evaluation.
