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510(k) Data Aggregation

    K Number
    K093790
    Device Name
    SIMONDR DRP
    Manufacturer
    Date Cleared
    2010-04-05

    (116 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMONDR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Models SimonDR DRP Digital X-Ray Imager is a digital x-ray Imager intended for physicians or technologists operating under the guidance of the physician, to use for diagnostic x-ray imaging in podiatric practices instead of using a film based system.
    Device Description
    The SimonDR Inc. model DRP is used to directly capture and convert conventional projection X-Ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for podiatric radiographic examinations.
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