Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K954943
    Device Name
    NEVOSCOPE
    Manufacturer
    Date Cleared
    1996-03-27

    (149 days)

    Product Code
    Regulation Number
    880.6320
    Why did this record match?
    Product Code :

    KZF

    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.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1