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510(k) Data Aggregation

    K Number
    K980295
    Device Name
    OPHTHAVISION IMAGING SYSTEM
    Manufacturer
    MRP GROUP, INC.
    Date Cleared
    1998-05-19

    (112 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MRP GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OphthaVision Imaging System is intended to be used to capture, archive and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
    Device Description
    The OphthaVision Imaging System consists of: (1) a digital camera; (2) an imaging board: (3) a personal computer; (4) a monitor; and (5) MRP Group Inc.'s Microsoft Windows based image processing software. The OphthaVision Imaging System is used in ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp or a fundus camera. Images are transferred to the OphthaVision Imaging System's imaging board, located in the OphthaVision Imaging System's personal computer and stored in the computer's Random Access Memory (RAM) and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to manipulate the software interface.
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