Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122311
    Device Name
    GC-3000E DIGITAL COLPOSCOPE
    Date Cleared
    2013-09-18

    (413 days)

    Product Code
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN GOLDCARE MEDITECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GC-3000E Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.
    Device Description
    GC-3000E is a digital colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. GC-3000E is used to diagnose abnormalities and select areas for biopsy. GC-3000E acquires and displays high-resolution still and sequentially captured images and videos. GC-3000E offers non-patient contact, fully digital and high-resolution imaging of the cervix. The field of view is illuminated by circular LED group light source; a high-resolution color CCD camera provides crisp magnified color images. The images can be viewed on a commercially available color monitor. Components: Digital Camera, Vertical Stand
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1