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510(k) Data Aggregation

    K Number
    K041805
    Device Name
    MICROSCOPE SYSTEM
    Date Cleared
    2004-09-21

    (77 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIRAS MIRROR IMAGING SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MirroScope™ System is indicated for use during dental examinations and procedures when a video image is desired.
    Device Description
    The MirroScope™ System is an intraoral camera that is mounted on a customary mirror and complimentary imaging accessories. The System consists of the following main components: 1. The MirroScope™: a handpiece comprised of a mirror (MirroLens), alignment of prisms and lenses, a miniature 1/4" CCD camera Remote Head Unit (RHU), located in the handle. The video signal from the RHU is transferred to the Camera Control Unit (CCU) located in a control box, via a lightweight cable. A set of six LED's illuminates the working area around the mirror. A disposable, single use protective sheath is provided to be mounted over the handpiece prior to each use, to ensure proper hygiene and to serve as a barrier cover. 2. Two complementary packages, the PRO-200™ and the VIEW-300™, to provide either an overall solution or an add-on solution to the existing infrastructure. The PRO-200™ includes a Control Box (Camera Control Unit (CCU), Video Processing Unit (VPU), Power Supply Unit (PSU), RF Transmitter (Optional), Infrared Receiver (IRR), Docking station for MirroScope™), R-400 Infrared remote control, External AC/DC adaptor, Foot pedal (Optional), and RF Receiver (Optional). The VIEW-300™ includes a Control box (Camera Control Unit (CCU), Video Processing Unit (VPU), Power Supply Unit (PSU), 12.1" TFT screen and Converter, Infrared Receiver (IRR), Docking station for MirroScope™), R-400 Infrared remote control, External AC/DC adaptor, Accessories, and Foot pedal (Optional).
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