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510(k) Data Aggregation
K Number
K954943Device Name
NEVOSCOPE
Manufacturer
Date Cleared
1996-03-27
(149 days)
Product Code
Regulation Number
880.6320Why did this record match?
Applicant Name (Manufacturer) :
NIZAR A. MULLANI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Not Found
Device Description
Nevoscope is a hand-held, skin examination microscope that is similar in concept to the Episcope (k920103) and the Dermatoscope devices approved by the FDA. It is a non invasive device that is designed to view skin lesions by either surface illumination or transillumination. Light is directed onto the skin by a special light ring that is coupled to an AC powered halogen lamp by an optical fiber bundle. Built-in mirrors permit viewing a skin lesion from different elevations and angles simultaneously. A variable focus zoom lens controls the magnification of the lesion and a CCD TV camera is attached for image viewing and digitization. Skin lesion images can be stored in the computer for analysis and archiving.
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