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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR892.1990]
See Related Information on Transilluminator for breast evaluation. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 892 -- RADIOLOGY DEVICES

Subpart B--Diagnostic Devices

Sec. 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.

[60 FR 36639, July 18, 1995]

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