CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 892—RADIOLOGY DEVICES > SUBPART B—Diagnostic Devices (§892.1000 to §892.2050) > 892.1990—Transilluminator for breast evaluation.

892.1990—Transilluminator for breast evaluation.

(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.

Code of Federal Regulations

[60 FR 36639, July 18, 1995]