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510(k) Data Aggregation

    K Number
    K040171
    Device Name
    MICRODERM, MODEL/VERSION 3.5
    Manufacturer
    VISIOMED AG
    Date Cleared
    2004-06-08

    (134 days)

    Product Code
    PSN, LLZ
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISIOMED AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.
    Device Description
    MicroDERM® is a digital dermascope and software system, which captures images of skin surfaces for physician diagnostic review and referral purposes. These images can be sent to other computers using a modem or network card. It consists of the MicroDERM® camera, MicroDERM® software, and a frame grabber card. The MicroDERM® software runs under the Microsoft® Windows 2000 operating system. MicroDERM is not intended as a diagnostic device.
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